The usa Food and Drug management (Food And Drug Administration) today authorized bremelanotide (Vyleesi, AMAG Pharmaceuticals), a first-in-class melanocortin 4 receptor agonist for hypoactive sexual interest disorder (HSDD) in premenopausal females.
It joins flibanserin (Addyi, Sprout Pharmaceuticals), the sole other HSDD that is FDA-approved treatment premenopausal females.
The FDA had until June 23 to accomplish the review of bremelanotide’s brand new drug application (NDA) underneath the approved Drug consumer Fee Act (PDUFA).
HSDD impacts about 10% of most premenopausal feamales in america, or just around 6 million ladies, stated Julie Krop, MD, main officer that is medical administrator vice president of medical development and regulatory affairs at AMAG Pharmaceuticals. Continue reading