Cadila Health gains after USFDA grants fast track designation to Saroglitazar

Cadila Healthcare rose 1.14% to Rs 470.25 after the US drug regulator granted fast track designation to the company for Saroglitazar in the treatment of patients with Primary Biliary Cholangitis (PBC).

In a BSE filing made during market hours today, the company said that the treatment options are still evolving for primary biliary cholangitis and Saroglitazar holds immense potential based on its safety and efficacy profile so far.

Fast Track is a process of the USFDA which expedites the review of drugs to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation is eligible for Accelerated Approval and Priority Review, if the relevant criteria are met. The purpose is to get important new drugs to the patients faster.

"The global market for primary biliary cholangitis treatment is expected to grow at a CAGR of 36.3% from 2018 - 2026 and is expected to reach USD 10.8 bn by 2026 as per Coherent market insights," Cadila Healthcare said in a statement.

Cadila Healthcare is a global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

The company's consolidated net profit soared 411% to Rs 423.60 crore on 16% jump in net sales to Rs 3,762.30 crore in Q2 September 2020 over Q2 September 2019.

Powered by Capital Market - Live News