Gedeon Richter's Esmya 5mg tablet has received European Commission (EC) approval for the aspre-operative treatment of moderate to severe symptoms of uterine fibroids.
The approval follows positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The Esmya 5mg tablet, containing ulipristal acetate, is a first-in-class, orally active, selective progesterone receptor modulator that acts by blocking the progesterone receptors in target tissues.
The approval is backed by pre-clinical data, quality data, and clinical data involving 498 subjects treated with Esmya, which includes data from the two Phase III pivotal clinical studies, Pearl I and Pearl II.
The randomised parallel-group double-blind placebo-controlled phase III Pearl I trial showed that uterine bleeding was controlled in 91% of women receiving ulipristal acetate 5mg, in 92% of those receiving ulipristal acetate 10mg, and in 19% of those receiving placebo.
Pearl II is a double-blind double-dummy phase III trial, which demonstrated that uterine bleeding was controlled in 90% of patients receiving ulipristal acetate 5mg, in 98% of those receiving ulipristal acetate 10mg, and in 89% of those receiving leuprolide acetate.
In the Pearl II trial, all treatments reduced the volume of the three largest fibroids, with median reductions at week 13 of 36% in the group receiving ulipristal acetate 5mg, 42% in the group receiving ulipristal acetate 10mg, and 53% in the group receiving leuprolide acetate.
Gedeon Richter managing director Erik Bogsch said: "This approval is a result of outstanding work done by our PregLem team. We are delighted to bring the benefits of Esmya to patients and physicians in the EU in need of highly effective and convenient therapy for women suffering from uterine fibroids."
PregLem CEO Ernest Loumaye added: "Esmya offers an effective and well-tolerated therapeutic option, while avoiding the drawbacks of currently available therapies."
Lead investigator of Pearl I and II trials professor Jacques Donnez said Pearl I and II clinical studies showed the benefits of Esmya as a pre-surgical treatment for uterine fibroids in the rapid control of bleeding and reduction in fibroid size.
"These will help patients to be in a better condition for the surgery and possibly have a minimal invasive surgery," Donnez explained.
PregLem, the wholly owned subsidiary of Richter, is focused on the development and commercialisation of a new class of drugs for women's reproductive health conditions.