Gedeon Richter and Sumitomo Pharma Receive the EMA’s CHMP Positive Opinion of Ryeqo for Treatment of Endometriosis
Shots:
- The EMA’s CHMP has adopted a positive opinion recommending the approval of a Type II Variation application for Ryeqo (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) to treat symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis. The EC’s final decision on MAA is expected in the coming months
- The application was based on the two, 24wk. clinical studies (SPIRIT 1 & 2) in 1200+ women with mod. to sev. pain associated with endometriosis, as well as the 80wk. OLE study of Ryeqo
- Ryeqo was approved by the EMA for mod. to sev. symptoms of uterine fibroids in adult women of reproductive age. The decision will be valid to all member states of the EEA
Ref: Gedeon Richter | Image: Gedeon Richter
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
