The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for ulipristal acetate (Gedeon Richter) for preoperative treatment of uterine fibroids.
Ulipristal acetate is a selective progesterone receptor modulator that deprives uterine fibroids of growth stimulation due to progesterone. Ulipristal acetate reduces fibroid-related bleeding, anemia, and fibroid size, the committee said in a statement.
According to the CHMP, "Ulipristal acetate is indicated for one treatment course of preoperative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery."
Upon approval by the European Commission, ulipristal acetate will be available as 5-mg tablets.
The most common side effects are amenorrhea, endometrial thickening, and hot flush. Ulipristal acetate should be prescribed by physicians experienced in the diagnosis and treatment of uterine fibroids, the CHMP advised.
The application for ulipristal acetate for this indication was an informed consent application, which makes use of data from the dossier of a previously authorized reference medicine. The reference product for ulipristal acetate is Esmya.
However, European Union drug regulators have expressed concern about Esmya in the past.
As previously reported by Medscape Medical News, in December 2017, the EMA opened an investigation into possible liver injury associated with the drug, and in February 2018, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended liver function testing at least monthly for women taking Esmya for uterine fibroids.
Cite this: EMA Backs Ulipristal for Preop Treatment of Uterine Fibroids - Medscape - Jun 29, 2018.