Gedeon Richter Plc. (“Richter”) announces today that the European Commission has granted marketing authorisation to Esmya® 5mg tablet as
pre-operative treatment of moderate to severe symptoms of uterine fibroids.
This decision follows positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency on 16 December 2011 and is applicable for all Member States in the European Union.
- Ulipristal acetate controlled bleeding in over 90% of patients.
- Excessive bleeding was controlled significantly more rapidly with ulipristal acetate than with leuprolide acetate.
- Ulipristal acetate significantly reduced fibroid size and for patients who did not undergo surgery, the volume reduction was maintained for at least 6 months after treatment is discontinued.
The approval is based on the assessment of extensive pre-clinical data, quality data, and clinical data involving 498 subjects treated with Esmya®, which include data from the two Phase III pivotal clinical studies, PEARL I and PEARL II.
“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, ", said Erik Bogsch, Managing Director of Gedeon Richter Plc. “We remain committed to the development of female healthcare products which improve quality of life for the female population in all age groups.”
“Today’s approval of Esmya® means that thousands of patients suffering from fibroids across Europe will now have a new targeted approach for medical treatment of these benign tumours. Esmya® offers an effective and well-tolerated therapeutic option, while avoiding the drawbacks of currently available therapies”, said Dr. Ernest Loumaye, Chief Executive Officer of PregLem.
“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” added Prof. Jacques Donnez, lead investigator in PEARL I and II.