BioCentury
ARTICLE | Clinical News

Allergan uterine fibroids therapy hits regulatory setback

August 31, 2018 6:46 PM UTC

Allergan plc (NYSE:AGN) said FDA issued a complete response letter for its NDA for ulipristal acetate to treat abnormal uterine bleeding in women with uterine fibroids. The company said FDA requested additional information and cited safety concerns from ex-U.S. postmarketing reports.

Gedeon Richter plc (Budapest:RICHTER) markets ulipristal as Esmya in Europe for the same indication. The company has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma S.A. (Paris, France). Allergan, which has rights to the drug in the U.S. and Canada under a 2010 deal, markets ulipristal in Canada as Fibristal. The compound is a selective progesterone receptor modulator (SPRM)...