BridgeBio, Sentynl, and Medison Reports the Approval of Nulibry in Israel for the Treatment of Molybdenum Cofactor Deficiency Type A
Shots:
- The approval was based on the results from 3 studies evaluating the efficacy of Nulibry in patients with MoCD Type A vs data from natural history with results demonstrating a reduced risk of death (82%) & increased probability of survival (84%) @3yrs. vs 55% in the historical control group
- The US FDA approved Nulibry in Feb’21 for reducing the mortality rate of patients with MoCD Type A whereas, following the CHMP recommendation, an application for the marketing approval for Nulibry in the EU is expected to be submitted in 2022
- In Dec’19, Medison acquired the commercialization rights of Nulibry in Israel whereas Sentynl acquired the global rights for the development & commercialization of Nulibry in Mar’22. Sentynl & BridgeBio co-share the development responsibilities through MAA under accelerated assessment with the EMA
Ref: PR Newswire | Image: Bridgebio
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