Addyi flibanserin regulatory update

FDA’s Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees voted 18-6 that the benefit/risk profile of Addyi flibanserin from Sprout supports approval to treat hypoactive sexual desire disorder (HSDD) in premenopausal women -- but only with risk management plans. The resubmitted NDA has an Aug. 18 PDUFA date (see BioCentury, Feb. 23).

Several committee members who supported approval of the serotonin (5-HT1A) receptor agonist and 5-HT2A receptor antagonist said they did so with reservations. Some said the fact that there are no approved treatments for HSDD influenced their votes. Many supported implementation of a REMS, suggested prescriber certification and supported postapproval studies to better define risks associated with alcohol use and pregnancy. ...