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.