FDA delays approval of Esmya, issuing CRL

The US Food and Drug Administration has issued a Complete Response Letter (CRL) in response to the New Drug Application (NDA) for Esmya (ulipristal acetate; UPA) for the treatment of abnormal uterine bleeding in women with uterine fibroids.

Ireland-incorporated Allergan (NYSE: AGN) noted that 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 USA. Allergan plans to meet with the FDA to discuss their comments and next steps.

"Allergan continues to believe in the need for novel treatment options for women who are looking for a non-surgical treatment for uterine fibroids," said David Nicholson, chief R&D officer at Allergan.  "We intend to meet with the FDA to discuss the Complete Response Letter and determine the potential next steps for our ulipristal acetate NDA."