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Monthly News Roundup - June 2019

Vyleesi: A Second Drug Approved to Boost Libido in Women


In June the U.S. Food and Drug Administration (FDA) approved Vyleesi (bremelanotide injection) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is characterized by low sexual desire not due to co-existing health conditions, relationship problems or drug side effects.

  • Vyleesi, from AMAG Pharmaceuticals is the second female libido drug to gain FDA approval after Sprout’s Addyi (flibanserin) in 2015; however, with Vyleesi, there is no warning for combined alcohol use.
  • Classified as a melanocortin receptor agonist, it comes as a self-administered autoinjector used 45 minutes prior to sexual activity
    In two clinical trials of close to 1,200 women, roughly 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (range of 1.2 to 6.0, higher scores equal greater sexual desire) compared to 17% of those who took placebo.
  • Common side effects included nausea (40%), flushing (20%), injection site reactions (3%), and headache (11%). Vyleesi should not be used in women with uncontrolled high blood pressure or other known heart risks.

Genentech’s Polivy Gains Accelerated FDA Approval for Aggressive Lymphoma

Diffuse large B-cell lymphoma (DLBCL) is a fast-growing type of non-Hodgkin’s lymphoma (NHL), a form of blood cancer. Up to 40% of patients can relapse, leaving them with few options and a shorter lifespan.

  • This month the FDA granted accelerated approval to Polivy (polatuzumab vedotin-piiq) used with bendamustine plus rituximab (BR) for the treatment of adults with relapsed or refractory DLBCL after at least two prior therapies. Polivy is a novel CD79b-ected antibody–drug conjugate.
  • In Phase Ib/II studies, 40% of people treated with Polivy plus BR reached the primary endpoint of complete response, meaning no cancer could be detected at assessment, compared to 18% with BR alone.
  • Side effects include low white blood cell counts, numbness, tingling or pain in the hands and feet, and diarrhea, among others.

Lilly’s Emgality is First CGRP Inhibitor Approved for Cluster Headache

Cluster headaches can be seasonal, produce extreme pain and occur in clusters for several weeks to months at a time. They can strike several times a day, often lasting between 15 minutes and three hours and frequently occur at the same time each day.

  • This month the FDA broadened the use of Emgality (galcanezumab-gnlm) injection, a calcitonin gene-related peptide (CGRP) antibody, for the treatment of episodic cluster headache in adults. Emgality is given by self-injection.
  • In a 3-week placebo-controlled study with 106 patients, those taking Emgality experienced 8.7 fewer weekly cluster headache attacks than they did at the beginning of the study (at baseline), compared to 5.2 fewer attacks for patients on placebo.
  • The most common side effect is injection site reactions. Serious allergic reactions may also occur.

Kanjinti: Latest Herceptin Biosimilar for Breast, Gastric Cancer

The FDA has approved Kanjinti (trastuzumab-anns) for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

  • Kanjinti, a HER2/neu receptor antagonist from Amgen and Allergan is approved for all of the indications of Genentech’s Herceptin (trastuzumab), the reference product.
  • Kanjinti is the fifth approved trastuzumab biosimilar product, after Ogivri, Herzuma, Ontruzant, and Trazimera.
  • In studies, Kanjinti was shown to be highly similar to Herceptin without meaningful clinical differences.
  • The most common adverse reactions associated with trastuzumab include: fever, nausea, vomiting (in breast cancer use) and neutropenia, diarrhea, fatigue (in gastric cancer use), among others.

FDA Approves Pfizer’s Zirabev As a Second Biosimilar to Avastin

In June, the FDA approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab).

  • Zirabev is approved for the same five types of cancer as Mvasi (bevacizumab-awwb), the first approved Avastin biosimilar: metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, and cervical cancer.
  • Zirabev is not approved for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer as found in the U.S. Avastin label.
  • Research demonstrated biosimilarity with no clinically meaningful differences of Zirabev to the reference product.
  • Common side effects include nose bleeds, headaches, high blood pressure, rhinitis (runny, stuffy nose), and protein in the urine, among others.

FDA Clears Victoza Injection for Type 2 Diabetes in Children

The FDA has approved Victoza injection from Novo Nordisk for treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist and was previously approved to treat adults with type 2 diabetes in 2010.

  • In a placebo-controlled study with 134 children 10 years and older, roughly 64% of patients had a reduction in their hemoglobin A1c (HbA1c) below 7% while on Victoza, compared to only 37% who achieved these results with the placebo. HbA1c measures average blood sugar levels over the last few weeks or months.
  • Victoza is the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000.
  • Victoza contains a Boxed Warning for increased risk of thyroid C-cell tumors, and common side effects include nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation.

Dupixent is First Biologic for Rhinosinusitis with Nasal Polyps

The FDA has cleared Regeneron’s Dupixent (dupilumab) injection as an add-on maintenance treatment for adults with nasal polyps (growths on the sinuses) accompanied by chronic rhinosinusitis (sinus and nasal cavity swelling). Nasal polyps can lead to breathing difficulties, nasal congestion and loss of smell requiring surgery to remove the polyps.

  • Dupixent, an interleukin-4 receptor alpha antagonist, is the first option approved for patients with uncontrolled rhinosinusitis and nasal polyps.
  • Phase 3 studies included 724 patients who did not respond adequately to intranasal corticosteroids. Results demonstrated a statistically significant reduction in nasal polyp size (33% and 27% reduction) and nasal congestion (57% and 51% improvement) compared to the placebo group (7% and 4% increase in polyp size; 19% and a 15% improvement in nasal congestion, respectively).
  • Common side effects include injection site reactions and eye inflammation. Dupixent is also approved for use in eczema and as an add-on maintenance treatment in asthma.

Posted: June 2019

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