Welcome to Gedeon Richter PregLem
Developing first-in-class therapies for gynaecologic conditions with significant unmet needsLearn more
Gedeon Richter PregLem SA is a Swiss-based speciality biopharmaceutical company dedicated to the development and commercialization of innovative drugs for women’s reproductive medicine. PregLem is a member of the Richter Group.
Completed Ph III
EMA approval as a pre-operative treatment of moderate to severe symptoms of uterine fibroids received in February 2012
(Steroid Sulfatase Inhibitor, STS-I)
Mild or Moderate Endometriosis: Phase IIa
(c-Jun-N-Terminal Kinase Inhibitor (JNK-I), Bentamapimod)
Inflammatory Endometriosis: Phase IIa / Proof of Concept (POC)
Adhesions: Phase IIa/Proof of Concept (POC)
(Somatostatin Antagonist, SST-ATG)
Ovarian Reserve Modulation: Pre-clinical development
European Commission approves Esmya® 5 mg for intermittent treatment in the long term management of Uterine Fibroids (myomas)
Budapest, Hungary – 28 May 2015 – Gedeon Richter Plc. (“Richter”) announces that the European Commission (EC) has granted approval for the intermittent use of Esmya® 5mg in the long term management of uterine fibroids. 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.