FDA indicates it cannot approve Allergan’s new drug application for ulipristal acetate

Allergan has disclosed that it has received a complete response letter (CRL) from the US Food and Drug Administration indicating that it cannot approve the new drug application (NDA) submitted for ulipristal acetate.

The NDA for ulipristal acetate (UPA) was submitted by Allergan for its use in the treatment of abnormal uterine bleeding in women with uterine fibroids. The FDA’s letter indicated, however, that it was unable to approve the ulipristal acetate NDA in its current form, citing safety concerns around the product’s post-marketing reports outside the US, and as such has requested additional information.

“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 research and development officer, 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.”

The NDA included results from a clinical trial programme, comprising two US Phase III clinical trials and all Phase III EU registration studies. Additionally, the company reported that the application included real-world data from more than 700,000 women with uterine fibroids across 80 countries worldwide.