Allergan’s ulipristal acetate rejected by FDA on safety grounds

Allergan’s investigational uterine fibroid drug Esmya has been on the market in the EU since 2012. However, reports of serious liver damage and even failure in patients on Esmya, confirmed by the EMA’s Pharmacovigilance Risk Assessment Committee, have led to the EMA implementing safety measures. Only patients who are not eligible for surgery can be subject to the selective progesterone receptor modulator for more than one treatment course. Further safety measures include liver tests before, during and after treatment, contraindication in women with known liver problems, and liver monitoring literature. Because of this, the US Food and Drug Administration (FDA) has rejected Allergan’s application to market ulipristal acetate.

David Nicholson, chief research and development officer said Allergan “intends to meet with the FDA to discuss the complete response letter and determine the next steps for ulipristal acetate NDA. Allergan continues to believe in the need for novel treatment options for women who are looking for a non-surgical treatment for uterine fibroids.”