Zydus' Saroglitazar Gets USFDA Priority Review for Rare Liver Disease PBC
New Delhi: Zydus Lifesciences has announced that the United States Food and Drug Administration (USFDA) has granted Priority Review to the New Drug Application (NDA) for saroglitazar, a therapy being developed for the treatment of Primary Biliary Cholangitis (PBC).
According to the company’s regulatory filing, the NDA was submitted by Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Limited.
The proposed indication seeks approval of saroglitazar for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adult patients who have shown an inadequate response to UDCA therapy. The company is also seeking approval for use of the drug as monotherapy in patients who are unable to tolerate UDCA.
Zydus stated that the US FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026, by which the agency is expected to complete its review of the application.
The company described the development as a significant regulatory milestone for saroglitazar and its innovation-led healthcare portfolio.
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