CHMP issues positive opinion on Richterʼs Esmya® 5 mg


The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the company’s application to extend the indication of Esmya® 5 mg tablets (ulipristal acetate) to long term repeated intermittent treatment of moderate to severe symptoms of uterine fibroids, Gedeon Richter Plc. said today in a press release.

The CHMP positive opinion will be forwarded to the European Commission, which is expected to amend the EU marketing authorization for Esmya® 5 mg applicable to all countries of European Union, within two months from the opinion.

Uterine fibroids are the most common benign, solid tumours of the female genital tract, affecting between 20 and 25 percent of women of reproductive age. The condition is characterized by excessive uterine bleeding, anaemia, pain, frequent urination or incontinence, and infertility.

Esmya® 5 mg containing ulipristal acetate, a new chemical entity, is a first-in-class, orally active, selective progesterone receptor modulator which reversibly blocks the progesterone receptors in target tissues, Richter said in the press release. The repeated intermittent 3-month treatment courses of once-a-day oral therapy is effective to stop uterine bleeding, correct anaemia, shrink fibroid volume and improve quality of life, the press release added. Esmya® has been developed by PregLem, the wholly owned subsidiary of Richter.

Richterʼs consolidated sales were approximately €1.1 bln ($ 1.5 bln), while its market capitalization amounted to €2.1 bln ($ 2.5 bln) in 2014. The product portfolio of Richter covers almost all important therapeutic areas, including gynaecology, central nervous system, and cardiovascular areas.


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