14. Vyleesi

FDA
(FDA)

Active ingredient: bremelanotide
Disease: hypoactive sexual desire disorder
Peak sales estimate: $170 million
Approved: June 21, 2019
Company: AMAG Pharmaceuticals

The scoop: For years, women with hypoactive sexual desire disorder looking for a treatment struggled with the alcohol contraindication problem linked to Sprout Pharmaceuticals’ Addyi. AMAG Pharmaceuticals wants to solve that with Vyleesi, which doesn’t bear any boxed warnings. But it is linked to a high rate of nausea, clinical data have shown. AMAG management has argued that most cases were mild to moderate and transient, pointing to the low dropout rate as evidence that symptoms are manageable. Approved by the FDA in June, the new female libido drug comes as an auto-injector, versus Addyi as a pill. While Addyi is taken daily, Vyleesi boasts the advantage of being administered on an as-needed basis. Still, analysts were not convinced Vyleesi could be a major success, despite a large patient population of about 5.8 million in the U.S. In a November note to clients, SVB Leerink’s Ami Fadia put the drug’s peak sales estimate at about $165 million. Amid Vyleesi’s launch, AMAG faced several distractions, including a proxy fight that recently ended with two board changes—which Fadia viewed as a cue for a strategic review—and the possibility of the FDA pulling premature-birth drug Makena off the market. — Angus Liu

14. Vyleesi

Suggested Articles

By redeploying staff, the FDA thinks it can respond to COVID-19-related requests and review protocols within 24 hours of receipt.

The partners leveraged their proximity to the initial outbreak and experience with SARS and MERS to build up a library of neutralizing antibodies.

CRISRP Therapeutics will likely be hit by the pandemic.