Pharmaceutical manufacturing facility with bioreactors and computer monitor
Zydus Therapeutics’ investigational drug, saroglitazar, has been granted priority review by the U.S. Food and Drug Administration (FDA). This designation signifies the FDA’s determination that saroglitazar may offer significant improvements over available therapy for patients with primary biliary cholangitis (PBC), a chronic liver disease.
Primary biliary cholangitis is a rare, progressive liver disorder characterized by inflammation and destruction of the bile ducts, leading to the buildup of bile in the liver. This can cause significant liver damage and eventually lead to cirrhosis and liver failure.
The company, a subsidiary of Cadila Healthcare (Zydus Lifesciences), has been developing saroglitazar for the treatment of advanced PBC. The drug has already received approval in India, where it is marketed as Saroglit. This priority review in the United States marks a significant step towards potentially making the treatment available to a wider patient population.
Zydus Therapeutics anticipates launching saroglitazar in the U.S. market in the fourth quarter of fiscal year 2027, pending successful regulatory review and approval. The priority review status is expected to expedite the FDA’s evaluation process.
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