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
