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BridgeBio Pharma and Sentynl Receive CHMP Positive Opinion of Nulibry (fosdenopterin) for the Treatment of MoCD Type A

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BridgeBio Pharma and Sentynl Receive CHMP Positive Opinion of Nulibry (fosdenopterin) for the Treatment of MoCD Type A

Shots:

  • The EMA’s CHMP has adopted a positive opinion recommending approval of Nulibry as 1st therapy for MoCD Type A. The EC’s decision is expected on the Nulibry application in 2022
  • The opinion was based on 3 clinical trials to evaluate Nulibry vs natural history which showed an 86% reduction in risk of death & increased the probability of survival to 86% @3yrs. over 52% of natural history study
  • If Nulibry is approved by EC, it will be the first approved therapy in the EU for MoCD Type A. Both the companies will share development responsibilities through the approval of the MAA under accelerated assessment with the EMA and through approval of Nulibry's regulatory submission with the Israeli Ministry of Health

Ref: PRNewswire | Image: BridgeBio Pharma

 

 

Click here to­ read the full press release 

Senior Editor

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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