The approval was based on the 2 P-III (PRIMROSE) trials evaluating Yselty (100/200mg, qd) with/out hormonal ABT in women aged ≥18yrs. with UF. The 24wk. results showed 84.5% responder rate in women with 200mg dose with hormonal ABT & 56.5% with 100mg without ABT
The linzagolix’ NDA is currently under the US FDA’s review in the US with an anticipated PDUFA date of Sept 2022. The EC decision is valid in all 27 EU member states, Iceland, Norway & Liechtenstein
In Feb 2022, ObsEva & Theramex collaborated to commercialize linzagolix across international markets outside of the US, Canada & Asia. ObsEva to receive $76.56M up front including ~$14.47M in development & commercial milestones, ~$56.83M in sales-based milestones along with royalties
Ref: Globenewswire | Image: ObsEva’
