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A company statement here claimed that Saroglitazar has demonstrated good efficacy in animal models of NASH, along with associated biomarkers. It has reduced hepatic steatosis, ballooning, inflammation and fibrosis in liver. Further, the recently completed phase 2 studies of Saroglitazar in patients with biopsy proven nonalcoholic fatty liver disease, have shown improvement in both liver enzymes along with favorable effects on lipid and glycemic indices.
Pankaj Patel, chairman and managing director, Zydus Cadila said, "There are currently no approved therapies to treat NASH. Saroglitazar is showing promise in NASH, and Zydus will continue further research to develop this important therapeutic for NASH patients."
NASH is a liver disease in which fat accumulates in the liver. Obesity, insulin resistance, diabetes and lipid disorders lead to NAFLD which progresses to lethal NASH situation. The diagnosis of NASH is most commonly carried out using liver biopsy and this condition can lead to cirrhosis and liver failure. This is currently an unmet healthcare need as there are currently no drugs approved for the treatment of NASH and patients often have to undergo liver transplant to survive.
LipaglynTM (Saroglitazar) was launched in September 2013 in India, for treating Hypertriglyceridemia and Diabetic Dyslipidemia in Patients with Type 2 Diabetes not controlled by statins. Since then, more than 60000 patients are availing this drug with a prescriber base over 3000 diabetologists, cardiologists and physicians. The group employs over 16,000 people worldwide including over 1200 scientists engaged in R&D and is dedicated to creating healthier communities globally.
