EMA approves Ulipristal for Preop Treatment of Uterine Fibroids

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) grants marketing authorization for Ulipristal Acetate (Gedeon Richter) as pre-operative treatment for uterine fibroids.

Ulipristal is a selective progesterone receptor modulator used for intermittent treatment for moderate to severe symptoms of uterine fibroids in women of reproductive age. It is also used as a pre-operative treatment in women scheduled for a uterine fibroid surgery, where it helps reduce bleeding, anemia and fibroid size. It will be available as 5 mg tablet upon approval.

The application for ulipristal approval was an informed consent application, which means that reference is made to an already authorized medication upon obtaining consent to the use of their dossier in the application procedure. The reference product for Gedeon Richter Ulipristal was Esmya.

The approval further recommends that the drug should only be prescribed by physicians who are experienced in the treatment of fibroids. The common side effects of the drug include endometrial thickening, amenorrhea, and hot flushes.

However, European Union drug regulators have expressed concerns about the side effects on the liver by Esmya in the past. In December 2017, the EMA opened an investigation about liver injury by the drug, followed by a monthly recommendation of liver function test in women taking Esmya by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).

Meanwhile, the United States FDA announced in February 2018 that it had extended the review of ulipristal new drug application (NDA) to August 2018.

  

Committee Statement

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