The US Food and Drug Administration (FDA) has approved Zydus Cadila’s plan to initiate a phase 2 clinical trial of saroglitazar in patients with non-alcoholic steatohepatitis (NASH) of the liver. NASH is the area of significant unmet medical need in the USA with an estimated 6.5 million adults in the US and five major European countries having advanced NASH, a liver disease in which fat accumulates in the liver.
Obesity, insulin resistance, diabetes and lipid disorders lead to NAFLD which progresses to a lethal NASH situation. The diagnosis of NASH is most commonly carried out using liver biopsy and this condition can progress to cirrhosis and liver failure. Liver transplantation is the only treatment for advanced cirrhosis with liver failure. NASH ranks as one of the major causes of cirrhosis in America, behind hepatitis C and alcoholic liver disease. Biotech Analysts estimate the worldwide market for NASH medicines to reach $ 35-40 billion by 2025.
Pankaj Patel, chairman and managing director of Zydus Cadila, said, “NASH is an area of unmet healthcare need as there are currently no drugs approved for the treatment of NASH. Saroglitazar has significant and differentiated effect on hepatic steatosis, while it shows all other beneficial effects on reducing inflammation and fibrosis in the liver in NASH models. With a phase III trial in biopsy proven NASH patients ongoing in India and a phase II trial in NASH patients planned in USA, we are committed towards developing this drug for millions of patients suffering from NASH”.
Zydus had earlier initiated a phase III clinical trial of Lipaglyn (saroglitazar) in India to treat patients with biopsy proven NASH. Saroglitazar has demonstrated good efficacy in animal models of NASH, along with associated biomarkers. The recently concluded phase 2 studies of saroglitazar in patients with biopsy proven NASH has shown improvement in liver enzymes along with favourable effects on lipid and glycemic indices.
Obesity, insulin resistance, diabetes and lipid disorders lead to NAFLD which progresses to a lethal NASH situation. The diagnosis of NASH is most commonly carried out using liver biopsy and this condition can progress to cirrhosis and liver failure. Liver transplantation is the only treatment for advanced cirrhosis with liver failure. NASH ranks as one of the major causes of cirrhosis in America, behind hepatitis C and alcoholic liver disease. Biotech Analysts estimate the worldwide market for NASH medicines to reach $ 35-40 billion by 2025.
Pankaj Patel, chairman and managing director of Zydus Cadila, said, “NASH is an area of unmet healthcare need as there are currently no drugs approved for the treatment of NASH. Saroglitazar has significant and differentiated effect on hepatic steatosis, while it shows all other beneficial effects on reducing inflammation and fibrosis in the liver in NASH models. With a phase III trial in biopsy proven NASH patients ongoing in India and a phase II trial in NASH patients planned in USA, we are committed towards developing this drug for millions of patients suffering from NASH”.
Zydus had earlier initiated a phase III clinical trial of Lipaglyn (saroglitazar) in India to treat patients with biopsy proven NASH. Saroglitazar has demonstrated good efficacy in animal models of NASH, along with associated biomarkers. The recently concluded phase 2 studies of saroglitazar in patients with biopsy proven NASH has shown improvement in liver enzymes along with favourable effects on lipid and glycemic indices.