FDA rejects Allergan's Esmya to treat bleeding associated with uterine fibroids

Allergan announced Tuesday that the FDA has issued a complete response letter regarding its marketing application for Esmya (ulipristal) for the treatment of abnormal uterine bleeding in women with uterine fibroids. According to Allergan, the FDA is requesting additional information and cited safety concerns regarding post-marketing reports outside the US.

The drug is already approved in Europe, where it is marketed by partner Gedeon Richter for the pre-operative and intermittent treatment of moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age. The therapy is marketed in Canada by Allergan under the name Fibristal for the intermittent treatment of moderate-to-severe signs and symptoms of uterine fibroids.

Earlier this year, European regulators imposed temporary restrictions on use of the drug following reports of serious liver injury, including liver failure leading to transplantation. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee concluded in May that Esmya may have contributed to the development of some cases of serious liver injury, and recommended that several measures be implemented to minimise the risk.

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Commenting on the FDA rejection, Allergan's R&D chief David Nicholson said the company "continues to believe in the need for novel treatment options for women who are looking for a non-surgical treatment for uterine fibroids." He added "we intend to meet with the FDA to discuss the complete response letter and determine the potential next steps for our…[new drug application]."

Allergan noted that its US filing for Esmya was supported by Phase III data from the VENUS I and VENUS II trials involving more than 500 adult women of reproductive age.

CEO Brent Saunders, who recently confirmed that the drugmaker plans to sell its women's health business, indicated recently that a sale of the unit might be delayed by the FDA's decision earlier this year to extend its review of Esmya.