USFDA allows fast track development for Zydus' liver drug Saroglitazar

India's new pharmaceutical drug development ambitions got a fillip as Ahmedabad-based Zydus Cadila got 'Fast Track Designation' by the US Food and Drug Administration (USFDA) for Saroglitazar in the treatment of patients with Primary Biliary Cholangitis (PBC), a liver disorder due to progressive destruction of the bile ducts.

Results of Phase 2 clinical trials to evaluate the safety, tolerability and efficacy of 'Saroglitazar Mg' in patients with liver disorders were presented earlier at the 'The Liver Meeting 2020', the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). The treatment options are still evolving for PBC, which lead to reduction of bile flow - a condition referred to as cholestasis, which can be fatal. The drug aims to control Alkaline Phosphotase (ALP) or bilirubin, reduces strong side effects of existing drugs such as pruritus or increase in LDL-cholesterol and brings in better tolerance and efficacy. The global market for primary biliary cholangitis treatment is expected to grow at a CAGR of 36.3 per cent from 2018 to 2026 and is expected to reach $10.8 billion by 2026, as per Coherent market insights.

The Fast-Track approval 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.

"It is an important recognition by USFDA to address the serious condition and bridge an unmet medical need in the treatment of PBC patients. We are very thankful to the USFDA for their timely and useful feedback on the clinical trial designs of Saroglitazar Mg," says Pankaj R. Patel, Chairman, Zydus Cadila.

Saroglitazar was developed and launched by Zydus a few years ago in India, as India's first new chemical entity (NCE) - a diabetics drug capable of controlling high blood pressure and lipids.

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