Gedeon Richter Plc, a Hungary-based pharmaceutical company, along with Sumitomo Pharma America Inc (SMPA) and Sumitomo Pharma Switzerland GmbH (SMPS), subsidiaries of Japan-based Sumitomo Pharma Group, announced on Friday that they have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of a Type II Variation application for RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the symptomatic treatment of endometriosis in women with a history of earlier medical or surgical treatment for their endometriosis.
The European Commission (EC) is to review the CHMP recommendation and a final decision on the Marketing Authorisation Application is expected to be available in the coming months. The EC's decision is to be applicable to all member states of the European Economic Area.
The product was initially approved by the EMA in July 2021 for the treatment of moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age.
Dr Peter Turek, global head of Women's Health at Gedeon Richter, said: "Broadening the therapeutic reach of our core innovative products demonstrates our tireless pursuit of becoming a leading pharmaceutical company to address women's health issues. Once fully approved by the EC, this new therapy could offer a viable treatment option for many women living with endometriosis."
Pfizer's Hympavzi (marstacimab-hncq) receives US FDA approval for Hemophilia A or B treatment
Capricor begins BLA submission for deramiocel in Duchenne muscular dystrophy
GE HealthCare expands AI-enabled enterprise imaging with Blackford integration
Biogen receives FDA Breakthrough Therapy Designation for felzartamab
Inspira Technologies develops new disposable kit for perfusion market
Ananda Developments PLC signs contract for Phase 1 PK study on MRX1
Teva's Prolia biosimilar candidate accepted for review by FDA and EMA
Boehringer receives Breakthrough Therapy designation for survodutide
GBI Biomanufacturing agrees manufacturing collaboration with Allterum Therapeutics
Genprex research collaborators to present positive data on Reqorsa Gene Therapy at SITC 2024
ALK secures U.S. FDA approval for AccuTest Allergy Skin Testing Devices