Zydus Cadila gets USFDA Fast Track Designation for Saroglitazar

Drug firm Zydus Cadila on Wednesday said it has received Fast Track Designation from the US health regulator for its investigational drug candidate Saroglitazar Mg, indicated for the treatment of a liver disease - primary biliary cholangitis (PBC). Fast Track is a process of the USFDA to expedite 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, Zydus Cadila said in a statement.

The United States Food and Drug Administration (USFDA) has granted Fast Track Designation to Saroglitazar Mg for the treatment of patients with PBC, it added.

"The awarding of Fast Track Designation to Saroglitazar, an investigational candidate for the treatment of PBC, is an important recognition by USFDA to address the serious condition and bridge an unmet medical need in the treatment of PBC patients," Zydus Cadila Chairman Pankaj R Patel said. The company will continue to work closely with the USFDA for clinical development for Saroglitazar Mg for patients with PBC, he added.

PBC is a liver disease, caused due to the progressive destruction of the bile ducts in the liver, which leads to a reduction of bile flow - a condition referred to as cholestasis, the statement said. Shares of Cadila Healthcare, the listed entity of the Zydus Group, were trading at Rs 470.50 per scrip on BSE, up 1.19 per cent from its previous close.