Drug Development, FDA

FDA turns thumbs down on Allergan’s optimistic case for uterine fibroid drug as liver damage threat torpedoes application

One of Allergan’s $AGN top late-stage drugs just ran into a brick wall at the FDA.

The company noted Tuesday evening that the agency turned thumbs down on its marketing application to start selling ulipristal acetate for the treatment of abnormal uterine bleeding in women with uterine fibroids. The statement is a little hazy on specifics, but Allergan cited safety concerns raised outside the US — where the drug is already available.

Allergan had been upbeat about its late-stage data highlighting highly statistically significant efficacy data. And it badly needed a US approval to get this drug to the $1 billion blockbuster potential it outlined for investors.

The new bottom line:

The agency cited safety concerns regarding ESMYA post-marketing reports outside the United States. Allergan plans to meet with the FDA to discuss their comments and next steps.

And that could take a considerable amount of time to nail down, depending on the details of the CRL.

Allergan has been forced to rein in its marketing on the drug — sold as Esmya — in Europe as regulators raised concerns about the risk of rare but serious liver damage. The European group has restricted sales “following reports of serious liver injury, including liver failure leading to transplantation” which were linked to the drug.

All that, though, could add up to something worse than a single rejection might imply. Allergan CEO Brent Saunders said last May that the company was looking to sell its women’s health unit in order to right a listing stock price. But with Esmya under a dark cloud, it will be unlikely to fetch the price it needs to impress shareholders.

AbbVie, meanwhile, is pursuing an OK for elagolix for uterine fibroids, which scored it’s first approval just weeks ago for endometriosis.




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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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