Zealand Pharma and Boehringer Ingelheim Report the US FDA’s Breakthrough Therapy Designation of Survodutide for MASH
Shots:
- Zealand’s partner BI has received the US FDA’s BTD for survodutide to treat non-cirrhotic MASH & mod. or advanced fibrosis (stages 2 or 3). BI has also begun 2 P-III (LIVERAGE & LIVERAGE-Cirrhosis) studies for the same
- The P-III (LIVERAGE; n=1,800 & LIVERAGE-Cirrhosis; n=1,590) studies will assess survodutide (6mg, weekly) vs PBO in adults with MASH & fibrosis (stages 2-3) as well as MASH cirrhosis (stage 4), respectively
- The 1EPs of LIVERAGE include MASH resolution without worsening fibrosis & 1pt. fibrosis improvement without worsening MASH post 52wks. (part 1) as well as first occurrence of liver-related events or mortality for 7yrs. (part 2). LIVERAGE-Cirrhosis will track first occurrence of mortality or liver-related events for 4.5yrs.
Ref: Zealand Pharma | Image: Zealand Pharma & Boehringer Ingelheim
Related News:- Boehringer Ingelheim Reports the P-III (FIBRONEER-IPF) Trial Data of Nerandomilast to Treat Idiopathic Pulmonary Fibrosis (IPF)
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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.
