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ObsEva’s Yselty (linzagolix) Receive EC's Marketing Authorization for the Treatment of Uterine Fibroids

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ObsEva’s Yselty (linzagolix) Receive EC's Marketing Authorization for the Treatment of Uterine Fibroids

ObsEva’s Yselty (linzagolix) Receive EC's Marketing Authorization for the Treatment of Uterine Fibroids

Shots:

  • 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’

Click here to­ read the full press release 

Neha

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.

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