Complete Response Letter for Esmya for the treatment of abnormal uterine bleeding in women with uterine fibroids.- Allergan.

Allergan plc announced it received a Complete Response Letter (CRL) from the FDA in response to the New Drug Application (NDA) for ulipristal acetate (UPA) for the treatment of abnormal uterine bleeding in women with uterine fibroids. The letter from the FDA indicates it is not able to approve the ulipristal acetate NDA in its current form and is requesting additional information. 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.

Comment: The European Medicines Agency (EMA) has recommended that several measures be put in place to minimise the risk of rare but serious liver injury with Esmya (ulipristal acetate). However the CHMP in July 2018 recommended European approval .