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Pharma major Cadila Healthcare Limited on Wednesday announced that the company has received an approval from the US Food and Drug Administration (USFDA) for ‘Fast Track Designation’ to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC).
Saroglitazar Mg is a potent and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist.
Phase-2 results of a prospective, multi-centre randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of Saroglitazar Mg in patients with PBC were presented earlier at The Liver Meeting 2020, the annual meet of the American Association for the Study of Liver Diseases, the company informed.
Treatment options for PBC are still evolving, and Saroglitazar holds immense potential based on its safety and efficacy profile so far.
Commenting on the development, Pankaj Patel, Chairman, Zydus Cadila said: “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.”
“We are very thankful to the USFDA for its timely and useful feedback on the clinical trial designs of Saroglitazar Mg and will continue to work closely with the USFDA for clinical development of Saroglitazar Mg for patients with PBC,” said Patel.
‘Fast Track Designation’ is a process 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’ subject to the fulfilment of the set criteria. This route is used for getting important new drugs to the patients faster.
The global market for PBC treatment is expected to grow at a CAGR of 36.3 per cent from 2018-2026 and is expected to reach USD 10.8 bn by 2026 as per Coherent market insights.
PBC is a liver disease caused by the progressive destruction of the bile ducts in the liver which leads to reduction of bile flow — a condition referred to as cholestasis.
With an increasing number of people being affected by PBC, which can lead to progressive cholestasis and even turn fatal, there is a pressing need to develop therapies.
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