Myovant’s Ryeqo (relugolix, estradiol, and norethindrone acetate) Receives EC’s Approval for the Treatment of Women with Uterine Fibroids
Shots:
- The approval is based on safety & efficacy data from the P-III LIBERTY program that consists of 2 studies i.e LIBERTY 1 & 2 evaluating Ryeqo in adult women with UF with no limitation for a duration of use. The EC’s decision is valid in all 27 member states of the EU, Iceland, Norway & Liechtenstein
- The results showed that the therapy improved the symptoms i.e heavy menstrual bleeding & pain in a woman with UF and showed well-tolerated safety profile
- In Mar’2020, Myovant & Gedeon Richter collaborate to commercialize relugolix combination tablet for UF & endometriosis in EU, Russia, Latin America, Australia & New Zealand. The MAA for endometriosis is expected to submit in H2’21
Click here to read full press release/ article | Ref: GLOBE NEWSWIRE | Image: Myovant Sciences