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Zydus Cadila First Off The Block In NASH After India Approval

US Phase III Trials To Begin Q2 FY21

 
• By Vibha Ravi and Anju Ghangurde

Cadila Healthcare has received the first approval globally, in India, for a NASH therapy, after the national regulator cleared its candidate saroglitazar. The company also expects to begin Phase III trials in the US in the second quarter of fiscal 2021.

Approved
India Approves Cadila's NASH Drug • Source: Shutterstock

Zydus Cadila flagship firm Cadila Healthcare Ltd. has received marketing approval from the Drugs Controller General of India for its new chemical entity saroglitazar, to treat non-cirrhotic, non-alcoholic steatohepatitis (NASH), making it the first treatment to be approved for the condition globally and placing the Ahmedabad-based firm in the lead, for now, in a segment brimming with competition.

Pricing for the drug, to be launched three months from now, hasn’t been decided yet, Cadila chairman Pankaj Patel told...

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