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.

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.

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.

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.

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

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

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.

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.

Posted: June 2019