Replies to post #86293 on Biotech Values

[DewDiligence]

Re: Sex Really Is All in Her Head

Related (serious) posts from three years ago: #msg-13688286, #msg-15857810.

[DewDiligence]

FDA panel backs Sprout's Flibanserin for female HSDD* by 18-6 vote:

FDA panel votes 18-6 that #flibanserin's risk/benefit profile supports approval with some caveats for post-marketing surveillance

— Meg Tirrell (@megtirrell) June 4, 2015

Flibanserin used to be owned by B-I, who dropped the program after the FDA rejected the NDA five years ago (#msg-55308575, #msg-51358460, #msg-51467912,).

Flibanserin’s efficacy has never been especially convincing (#msg-43593174) and its safety has been questioned, but there is an unmet medical need for treatment of HSDD. Sprout Pharma “reformatted” the data package and solicited some heavy-duty lobbying by patient advocates; it seems to have worked—today’s panel was evidently more generous in its interpretation of the data.

See #msg-43570748, #msg-15857810, #msg-29181614 for (old) background info on this drug.

*Hypoactive Sexual Desire Disorder.