New Drug Approvals Archive - March 2017

Odactra (house dust mite allergen extract) Sublingual Tablets

Date of Approval: March 1, 2017
Company: ALK-Abelló A/S
Treatment for: House Dust Mite Allergies

Odactra (house dust mite allergen extract) is a sublingual allergy immunotherapy (SLIT) tablet indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis.

• FDA Approves Odactra for House Dust Mite Allergies
• Odactra (house dust mite allergen extract) FDA Approval History

Noctiva (desmopressin acetate) Nasal Spray

Date of Approval: March 3, 2017
Company: Serenity Pharmaceuticals, LLC
Treatment for: Nocturia

Noctiva (desmopressin acetate) is vasopressin analog nasal spray indicated for the treatment of nocturia due to nocturnal polyuria.

• FDA Approves Noctiva (desmopressin acetate) Nasal Spray for Nocturia in Adults
• Noctiva (desmopressin acetate) FDA Approval History

Kisqali (ribociclib) Tablets - formerly LEE011

Date of Approval: March 13, 2017
Company: Novartis Pharmaceuticals Corporation
Treatment for: Breast Cancer

Kisqali (ribociclib) is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6 indicated for the combination treatment of pre/perimenopausal or postmenopausal women with HR+/HER2- metastatic breast cancer.

• FDA Approves Kisqali (ribociclib) for HR+/HER2- Metastatic Breast Cancer
• Kisqali (ribociclib) FDA Approval History

Xadago (safinamide) Tablets

Date of Approval: March 21, 2017
Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease

Xadago (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.

• FDA Approves Xadago (safinamide) as an Add-On Treatment for Patients with Parkinson’s Disease
• Xadago (safinamide) FDA Approval History

Bavencio (avelumab) Injection

Date of Approval: March 23, 2017
Company: EMD Serono Inc.
Treatment for: Merkel Cell Carcinoma, Urothelial Carcinoma, Renal Cell Carcinoma

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) for Metastatic Merkel Cell Carcinoma
• Bavencio (avelumab) FDA Approval History

Symproic (naldemedine) Tablets

Date of Approval: March 23, 2017
Company: Shionogi Inc.
Treatment for: Opioid-Induced Constipation

Symproic (naldemedine) is a peripherally-acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation.

• FDA Approves Symproic (naldemedine) for the Treatment of Opioid-Induced Constipation
• Symproic (naldemedine) FDA Approval History

Zejula (niraparib) Capsules

Date of Approval: March 27, 2017
Company: GSK
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Zejula (niraparib) is an oral, poly ADP-ribose polymerase (PARP) inhibitor for the treatment of patients with ovarian, fallopian tube, or primary peritoneal cancer.

• Tesaro Announces FDA Approval of Zejula (niraparib) for Women with Recurrent Ovarian Cancer
• Zejula (niraparib) FDA Approval History

Dupixent (dupilumab) Injection

Date of Approval: March 28, 2017
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Atopic Dermatitis; Asthma; Chronic Rhinosinusitis with Nasal Polyposis

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated:

• for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
• as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: Not for the relief of acute bronchospasm or status asthmaticus.
• as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

• FDA Approves Dupixent (dupilumab) for Eczema
• Dupixent (dupilumab) FDA Approval History

Ocrevus (ocrelizumab) Injection

Date of Approval: March 28, 2017
Company: Genentech, Inc.
Treatment for: Multiple Sclerosis

Ocrevus (ocrelizumab) is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal nerve cell damage. Ocrevus is indicated as a treatment for both relapsing (RMS) and primary progressive (PPMS) forms of multiple sclerosis.

• FDA Approves Ocrevus (ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis
• Ocrevus (ocrelizumab) FDA Approval History