FDA Advisory Committee Recommends Ulipristal Acetate For Emergency Contraception

The committee’s vote followed a review of data from the Ulipristal Acetate preclinical and clinical development program, involving more than 4000 women from the US and Europe. The FDA is currently reviewing HRA Pharma’s new drug application (NDA) for Ulipristal Acetate.

Ulipristal acetate was approved in May 2009 by the European Commission for marketing as an emergency contraceptive within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

Earlier, the product was launched in October 2009 and is marketed currently in 22 European countries under the brand name ellaOne.

HRA Pharma is planning to seek marketing approvals in countries worldwide. In the US, HRA Pharma had submitted an NDA with the FDA in late 2009, and has entered into a licensing agreement with Watson Pharmaceuticals to commercialise this novel next-generation emergency contraceptive.

Erin Gainer, CEO of HRA Pharma, said: “HRA Pharma is pleased with the outcome of the Advisory Committee’s votes on the safety and effectiveness of ulipristal acetate. We look forward to working with the FDA to obtain approval for this new drug and offering a next-generation emergency contraceptive to women in the US.”