New Indications & Dosage Forms for Existing Drugs

Keytruda (pembrolizumab) for Injection

New Indication Approved: September 17, 2019
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

• FDA Approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma
• Keytruda approval history

Erleada (apalutamide) Tablets

New Indication Approved: September 17, 2019
Date of Original Approval: February 14, 2018

Erleada (apalutamide) is an oral androgen receptor inhibitor for the treatment of metastatic castration-sensitive prostate cancer, and non-metastatic castration-resistant prostate cancer.

• FDA Approves Erleada (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
• Erleada approval history

Nucala (mepolizumab) Injection

Patient Population Altered: September 12, 2019
Date of Original Approval: November 4, 2015

Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) indicated for the add-on maintenance treatment of patients with severe eosinophilic asthma, and for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome).

• FDA Approves Nucala (mepolizumab) for Six to 11-Year-Old Children with Severe Eosinophilic Asthma
• Nucala approval history

Ofev (nintedanib) Capsules

New Indication Approved: September 6, 2019
Date of Original Approval: October 15, 2014

Ofev (nintedanib) is a small molecule tyrosine kinase inhibitor (TKI) indicated for the treatment of idiopathic pulmonary fibrosis, and systemic sclerosis-associated interstitial lung disease (SSc-ILD).

• FDA Approves Ofev (nintedanib) for Interstitial Lung Disease Associated with Systemic Sclerosis or Scleroderma (SSc-ILD)
• Ofev approval history

Juvederm (dermal filler)

New Indication Approved: September 3, 2019
Date of Original Approval: June 2, 2006

Juvéderm is a hyaluronic acid dermal filler indicated for the correction of facial wrinkles and folds.

• FDA Approves Juvéderm Voluma XC For Mid-Face Injection Via Cannula
• Juvederm approval history

Taltz (ixekizumab) Injection

New Indication Approved: August 23, 2019
Date of Original Approval: March 22, 2016

Taltz (ixekizumab) is a humanized interleukin-17A antagonist indicated for the treatment of plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.

• FDA Approves Taltz (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)
• Taltz approval history

Myobloc (rimabotulinumtoxinB) Injection

New Indication Approved: August 20, 2019
Date of Original Approval: December 8, 2000

Myobloc (rimabotulinumtoxinB) is an acetylcholine release inhibitor indicated for the treatment of cervical dystonia and chronic sialorrhea.

• FDA Approves Myobloc (rimabotulinumtoxinB) Injection for Chronic Sialorrhea

Eylea (aflibercept) Injection

New Dosage Form Approved: August 13, 2019
Date of Original Approval: November 18, 2011

Eylea (aflibercept) is a VEGF inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

• FDA Approves Eylea (aflibercept) Injection Prefilled Syringe
• Eylea approval history

Sirturo (bedaquiline) Tablets

Patient Population Altered: August 9, 2019
Date of Original Approval: December 28, 2012

Sirturo (bedaquiline) is an oral diarylquinoline antimycobacterial drug indicated for the treatment of pulmonary multi-drug resistant tuberculosis.

• Janssen Announces U.S. FDA Accelerated Approval for Sirturo (bedaquiline) as Part of Combination Therapy to Treat Adolescents with Pulmonary Multidrug-Resistant Tuberculosis
• Sirturo approval history

Keytruda (pembrolizumab) for Injection

New Indication Approved: July 30, 2019
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

• FDA Approves Keytruda (pembrolizumab) for Recurrent Locally Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus
• Keytruda approval history

Otezla (apremilast) Tablets

New Indication Approved: July 19, 2019
Date of Original Approval: March 21, 2014

Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of psoriatic arthritis, plaque psoriasis, and oral ulcers associated with Behçet’s Disease.

• FDA Approves Otezla (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease
• Otezla approval history

Gadavist (gadobutrol) Injection

New Indication Approved: July 12, 2019
Date of Original Approval: March 14, 2011

Gadavist (gadobutrol) is a gadolinium-based contrast agent indicated for use in diagnostic magnetic resonance imaging (MRI).

• FDA Approves Gadavist (gadobutrol) Contrast Agent for Use in Cardiac MR in Adult Patients with Known or Suspected Coronary Artery Disease
• Gadavist approval history

Soliris (eculizumab) Injection

New Indication Approved: June 27, 2019
Date of Original Approval: March 16, 2007

Soliris is a complement inhibitor indicated for:

• the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
• the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy
• the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
• the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

• Alexion Receives FDA Approval of Soliris (eculizumab) for the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder
• Soliris approval history

Darzalex (daratumumab) Injection

New Indication Approved: June 27, 2019
Date of Original Approval: November 16, 2015

Darzalex (daratumumab) is a human anti-CD38 monoclonal antibody indicated for the treatment of patients with multiple myeloma.

• Janssen Announces FDA Approval of Darzalex (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible
• Darzalex approval history

Dupixent (dupilumab) Injection

New Indication Approved: June 26, 2019
Date of Original Approval: March 28, 2017

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated for the treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

• FDA Approves Dupixent (dupilumab) for Chronic Rhinosinusitis with Nasal Polyposis
• Dupixent approval history

Doptelet (avatrombopag) Tablets

New Indication Approved: June 26, 2019
Date of Original Approval: May 21, 2018

Doptelet (avatrombopag) is a second generation, orally administered thrombopoietin receptor agonist (TPO-RA) indicated for the treatment of:

• Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
• Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

• Dova Pharmaceuticals Announces FDA Approval of Doptelet (avatrombopag) for Treatment of Chronic Immune Thrombocytopenia (ITP)
• Doptelet approval history

Somatuline Depot (lanreotide acetate) Injection

New Dosage Form Approved: June 24, 2019
Date of Original Approval: August 30, 2007

Somatuline Depot (lanreotide) is a long acting somatostatin analogue indicated for the treatment of acromegaly, gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome.

• Ipsen Announces U.S. FDA Approval for Newly Designed Pre-Filled Syringe for Somatuline Depot (lanreotide)
• Somatuline Depot approval history

Symdeko (ivacaftor/tezacaftor and ivacaftor) Tablets

Patient Population Altered: June 21, 2019
Date of Original Approval: February 12, 2018

Symdeko (ivacaftor/tezacaftor tablets and ivacaftor tablets) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator and CFTR corrector combination for the treatment of cystic fibrosis in patients aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the CFTR) gene that is responsive to Symdeko.

• FDA Approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in the CFTR Gene
• Symdeko approval history

Botox (onabotulinumtoxinA) Injection

Patient Population Altered: June 20, 2019
Date of Original Approval: December 9, 1991

Botox (onabotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

• treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication
• treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication
• prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
• treatment of upper and lower limb spasticity in adult patients
• treatment of upper limb spasticity in pediatric patients 2 to 17 years of age
• treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain
• treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients
• treatment of blepharospasm associated with dystonia in patients 12 years of age and older
• treatment of strabismus in patients 12 years of age and older.

• FDA Approves Botox (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity
• Botox approval history

Dextenza (dexamethasone) Ophthalmic Insert

New Indication Approved: June 20, 2019
Date of Original Approval: November 30, 2018

Dextenza (dexamethasone ophthalmic insert) is a corticosteroid intracanalicular insert for the treatment of post-surgical ocular inflammation and pain.

• Ocular Therapeutix Announces FDA Approval of Dextenza (dexamethasone intracanalicular insert) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
• Dextenza approval history

Victoza (liraglutide) Injection

Patient Population Altered: June 17, 2019
Date of Original Approval: January 25, 2010

Victoza (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus, and to reduce the risk of heart attack, stroke and cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

• FDA Approves Victoza (liraglutide) for the Treatment of Pediatric Patients 10 Years or Older with Type 2 Diabetes
• Victoza approval history

Keytruda (pembrolizumab) for Injection

New Indication Approved: June 17, 2019
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

• FDA Approves Keytruda (pembrolizumab) for the Treatment of Metastatic Small Cell Lung Cancer (SCLC)
• Keytruda approval history

Keytruda (pembrolizumab) for Injection

New Indication Approved: June 10, 2019
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

• FDA Approves Keytruda (pembrolizumab) for First-Line Treatment of Head and Neck Squamous Cell Carcinoma
• Keytruda approval history

Emflaza (deflazacort) Tablets and Oral Suspension

Patient Population Altered: June 7, 2019
Date of Original Approval: February 9, 2017

Emflaza (deflazacort) is a glucocorticoid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

• PTC Therapeutics Receives FDA Approval for the Expansion of the Emflaza (deflazacort) Labeling to Include Patients 2-5 Years of Age
• Emflaza approval history

Nucala (mepolizumab) Injection

New Formulation Approved: June 6, 2019
Date of Original Approval: November 4, 2015

Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) indicated for the add-on maintenance treatment of patients with severe eosinophilic asthma, and for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome).

• Nucala (mepolizumab) Gains FDA Approval for Two New Self-Administration Options
• Nucala approval history

Emgality (galcanezumab-gnlm) Injection

New Indication Approved: June 4, 2019
Date of Original Approval: September 27, 2018

Emgality (galcanezumab-gnlm) is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine, and for the treatment of episodic cluster headache.

• FDA Approves Emgality (galcanezumab-gnlm) for the Treatment of Episodic Cluster Headache
• Emgality approval history

Zerbaxa (ceftolozane and tazobactam) Injection

New Indication Approved: June 3, 2019
Date of Original Approval: December 19, 2014

Zerbaxa (ceftolozane and tazobactam) is a cephalosporin and beta-lactamase inhibitor combination for the treatment of:

• complicated intra-abdominal Infections (cIAI), used in combination with metronidazole
• complicated urinary tract infections (cUTI), including pyelonephritis
• hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

• FDA Approves Zerbaxa (ceftolozane and tazobactam) 3g Dose for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
• Zerbaxa approval history

Revlimid (lenalidomide) Capsules

New Indication Approved: May 28, 2019
Date of Original Approval: December 27, 2005

Revlimid (lenalidomide) is a thalidomide analogue indicated for the treatment of adult patients with:

• Multiple myeloma (MM), in combination with dexamethasone.
• MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
• Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
• Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
• Previously treated follicular lymphoma (FL), in combination with a rituximab product.
• Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

• FDA Approves Revlimid (lenalidomide) In Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma
• Revlimid approval history

Jakafi (ruxolitinib) Tablets

New Indication Approved: May 24, 2019
Date of Original Approval: November 16, 2011

Jakafi (ruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of:

• intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults.
• polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.
• steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

• FDA Approves Jakafi (ruxolitinib) for the Treatment of Patients with Acute Graft-Versus-Host Disease
• Jakafi approval history

Vraylar (cariprazine) Capsules

New Indication Approved: May 24, 2019
Date of Original Approval: September 17, 2015

Vraylar (cariprazine) is a dopamine D₃/D₂ receptor partial agonist atypical antipsychotic for the:

• treatment of schizophrenia in adults
• acute treatment of manic or mixed episodes associated with bipolar I disorder in adults
• treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.

• FDA Approves Expanded Use of Vraylar (cariprazine) in the Treatment of Bipolar Depression
• Vraylar approval history

Fragmin (dalteparin sodium) Injection

Patient Population Altered: May 16, 2019
Date of Original Approval: December 22, 1994

Fragmin (dalteparin sodium) is a low molecular weight heparin (LMWH) indicated for:

• Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction
• Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness
• Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the Fragmin therapy begins with the initial VTE treatment and continues for six months
• Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month of age and older

• FDA Approves Fragmin (dalteparin sodium) as First Anticoagulant for Venous Thromboembolism in Pediatric Patients
• Fragmin approval history

Gattex (teduglutide) for Injection

Patient Population Altered: May 16, 2019
Date of Original Approval: December 21, 2012

Gattex (teduglutide) is a recombinant analog of human glucagon-like peptide 2 for the treatment of short bowel syndrome in adults and pediatric patients one year of age and older.

• FDA Approves Gattex (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)
• Gattex approval history

Venclexta (venetoclax) Tablets

New Indication Approved: May 15, 2019
Date of Original Approval: April 11, 2016

Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor indicated:

• for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
• in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

• AbbVie Announces US FDA Approval of Venclexta (venetoclax) as a Chemotherapy-Free Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia Patients
• Venclexta approval history

Bavencio (avelumab) Injection

New Indication Approved: May 14, 2019
Date of Original Approval: March 23, 2017

Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of patients with metastatic Merkel cell carcinoma (MCC); patients with advanced or metastatic urothelial carcinoma; and in combination with axitinib for patients with advanced renal cell carcinoma.

• FDA Approves Bavencio (avelumab) Plus Inlyta (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma
• Bavencio approval history

Eylea (aflibercept) Injection

New Indication Approved: May 13, 2019
Date of Original Approval: November 18, 2011

Eylea (aflibercept) is a VEGF inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

• FDA Approves Eylea (aflibercept) Injection for Diabetic Retinopathy
• Eylea approval history

Cyramza (ramucirumab) Injection

New Indication Approved: May 10, 2019
Date of Original Approval: April 21, 2014

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:

• as a single agent or in combination with paclitaxel, for treatment of advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
• in combination with docetaxel, for treatment of metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy.
• in combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
• as a single agent, for the treatment of hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib.

• Lilly's Cyramza (ramucirumab) Becomes First FDA-Approved Biomarker-Driven Therapy in Patients with Hepatocellular Carcinoma
• Cyramza approval history

Xeomin (incobotulinumtoxinA) Injection

New Indication Approved: May 10, 2019
Date of Original Approval: July 30, 2010

Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of cervical dystonia, blepharospasm, glabellar lines, upper limb spasticity, and excessive drooling.

• FDA Approves Broadened Indication for Xeomin (incobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients
• Xeomin approval history

Bivigam (immune globulin intravenous) Infusion

Labeling Revision Approved: May 10, 2019
Date of Original Approval: December 21, 2012

Bivigam is an immune globulin intravenous (human) indicated for the treatment of primary humoral immunodeficiency.

• ADMA Announces It Will Reintroduce Bivigam Into the Market
• Bivigam approval history

Sorilux (calcipotriene) Foam

Patient Population Altered: May 6, 2019
Date of Original Approval: October 7, 2010

Sorilux (calcipotriene) is a vitamin D analog indicated for the topical treatment of plaque psoriasis in patients 12 years and older.

• FDA Approves Sorilux for Adolescent Plaque Psoriasis
• Sorilux approval history

Kadcyla (ado-trastuzumab emtansine) Injection

New Indication Approved: May 3, 2019
Date of Original Approval: February 22, 2013

Kadcyla (ado-trastuzumab emtansine) is a HER2-targeted antibody and microtubule inhibitor conjugate indicated for the treatment of patients with HER2-positive, metastatic breast cancer.

• FDA Approves Genentech's Kadcyla for Adjuvant Treatment of People With HER2-Positive Early Breast Cancer
• Kadcyla approval history

Tibsovo (ivosidenib) Tablets

New Indication Approved: May 2, 2019
Date of Original Approval: July 20, 2018

Tibsovo (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor for the treatment of patients with acute myeloid leukemia who have an IDH1 mutation.

• Agios Announces FDA Approval of Tibsovo as Monotherapy for Newly Diagnosed Adult Patients with IDH1 Mutant Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy
• Tibsovo approval history

Mavyret (glecaprevir and pibrentasvir) Tablets

Patient Population Altered: April 30, 2019
Date of Original Approval: August 3, 2017

Mavyret (glecaprevir/pibrentasvir) is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, indicated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.

• FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients
• Mavyret approval history

Kalydeco (ivacaftor) Tablets and Oral Granules

Patient Population Altered: April 29, 2019
Date of Original Approval: January 31, 2012

Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients ages 6 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor.

• FDA Approves Kalydeco (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants with CF as Early as Six Months of Age
• Kalydeco approval history

Benlysta (belimumab) Injection

Patient Population Altered: April 26, 2019
Date of Original Approval: March 10, 2011

Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients with systemic lupus erythematosus.

• GSK Receives US Approval of Benlysta for Intravenous Use in Children with Lupus Aged Five Years and Above
• Benlysta approval history

Praluent (alirocumab) Injection

New Indication Approved: April 26, 2019
Date of Original Approval: July 24, 2015

Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody indicated:

• as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol LDL-C.
• to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

• FDA Approves Praluent (alirocumab) to Prevent Heart Attack, Stroke and Unstable Angina Requiring Hospitalization
• Praluent approval history

Keytruda (pembrolizumab) for Injection

New Indication Approved: April 19, 2019
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

• FDA Approves Keytruda (pembrolizumab) in Combination With Inlyta (axitinib) as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma (RCC)
• Keytruda approval history

Keytruda (pembrolizumab) for Injection

New Indication Approved: April 11, 2019
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

• FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC
• Keytruda approval history

Ibrance (palbociclib) Capsules

New Indication Approved: April 4, 2019
Date of Original Approval: February 3, 2015

Ibrance (palbociclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor for the combination treatment of ER+, HER2- metastatic breast cancer.

• FDA Approves Ibrance (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer
• Ibrance approval history

Zelnorm (tegaserod) Tablets

New Indication Approved: March 29, 2019
Date of Original Approval: July 24, 2002

Zelnorm (tegaserod) is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C)

• FDA Approves the Reintroduction of Zelnorm (tegaserod) for Irritable Bowel Syndrome with Constipation (IBS-C) in Women Under 65
• Zelnorm approval history

Cimzia (certolizumab pegol) Injection

New Indication Approved: March 28, 2019
Date of Original Approval: April 22, 2008

Cimzia (certolizumab) is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and non-radiographic axial spondyloarthritis.

• FDA Approves Cimzia (certolizumab pegol) for the Treatment for Non-Radiographic Axial Spondyloarthritis
• Cimzia approval history