CymaBay Reports the EMA’s Acceptance to Review the MAA of Seladelpar for Treating Primary Biliary Cholangitis (PBC)
Shots:
- CymaBay’s MAA for seladelpar has been accepted by the EMA for review to treat PBC incl. pruritus in adults without cirrhosis, with compensated cirrhosis (Child-Pugh A), with inadequate response or who are intolerant to ursodeoxycholic acid
- The MAA was based on the P-III (RESPONSE) trial results that showed improvements in itch associated with PBC & biochemical markers of disease progression. It was further supported by the P-III (ENHANCE) trial, (ASSURE) study, P-II trials & preclinical studies
- Seladelpar (oral) is a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist that can regulate the pathways of critical metabolic & liver disease
Ref: CymaBay Therapeutics | Image: CymaBay Therapeutics
Related News:- CymaBay Publishes Results for Seladelpar in P-III Trial for the Treatment of Primary Biliary Cholangitis in the NEJM
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
