Zydus gets nod from USFDA for Saroglitazar trials

The Dollar Business Bureau

Pharma company Zydus Cadila said that it has got approval from the US Food and Drug Administration (USFDA) to start clinical trials for phase II of Saroglitazar in patients with liver disease - non-alcoholic steatohepatitis (NASH).

The firm has received approval from the US health regulator to initiate randomised, double-blind phase II trial to analyse Saroglitazar in strengths of 4 mg, 2 mg and 1 mg against placebo.

Pankaj Patel, Chief Managing Director, Zydus Cadila, said, “NASH is a field of unfulfilled healthcare need as there is no approved drug for the treatment of this liver disease. Saroglitazar has major and distinguished effects on hepatic steatosis, whereas the drug highlights all other positive effects on lessening fibrosis and inflammation in the liver in non-alcoholic steatohepatitis models.”

“With phase III trial in biopsy proven NASH patients ongoing in India and a phase II trial in NASH patients planned in USA, the company is committed towards developing this drug for millions of patients suffering from NASH,” he added.

NASH is an area of considerable unmet medical requirement in the US with an expected 6.5 million youths in the US and five key countries in the Europe suffering from advanced NASH.

Non-alcoholic steatohepatitis or NASH is a liver disease wherein fat accumulates in the liver. The NASH is generally diagnosed by using liver biopsy. This disease can lead to chronic degenerative disease - cirrhosis and also to liver failure. The only cure for advanced cirrhosis and liver failure is liver transplantation.