PregLem Holding SA, the wholly owned subsidiary of Richter, is a Swiss speciality biopharmaceutical company, based in Geneva, dedicated to the development and commercialization of a new class of drugs for women’s reproductive health conditions.
In February 2012, PregLem announced full results of PEARL I and II studies on the use of ulipristal acetate (Esmya®) in the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
In the following months, the company filed for the initial marketing authorization by the European Commission, which was successfully granted.
In May 2015, Gedeon Richter Plc. announced that the European Commission (EC) has granted an extension to initial indication – an approval for the intermittent use of Esmya® 5mg in the long-term management of uterine fibroids (myomas). This decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 23 April 2015 and is applicable for all Member States in the European Economic Area.
The recent approval provides an opportunity for women to benefit from long-term medical management of uterine fibroids and potentially avoid surgery.
The approval is based on the assessment of two long-term Phase III studies, PEARL III extension and PEARL IV, involving 132 and 451 patients respectively, both designed to evaluate the efficacy and safety of ulipristal acetate (Esmya®) as a long-term treatment of uterine fibroids.