Allergan PLC said the U.S. Food and Drug Administration extended the review of the company's new drug application for ulipristal acetate for abnormal bleeding in the uterus due to fibroids.
The Prescription Drug User Fee Act target action date was extended to August to give the agency time to conduct a full review. The date had initially been expected to occur in the first half of 2018.
The Irish drugmaker had reported positive results from the second of two phase 3 clinical trials of ulipristal acetate as an oral treatment for abnormal bleeding due to uterine fibroids. However, in February, the European Medicines Agency panel advised patients against taking ulipristal acetate due to risk of liver injury.
The drug is also sold under the brand name Ella as an emergency contraceptive. In Europe, the treatment is marketed under the trade name Esmya by Gedeon Richter PLC and used to treat moderate to severe symptoms of uterine fibroids.
Fibroids are noncancerous tumors of the uterus.
