Zydus Cadila First Off The Block In NASH After India Approval

US Phase III Trials To Begin Q2 FY21

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...