DCGI approves Cadila’s Saroglitazar Mg for the treatment of Non-Alcoholic Fatty Liver Disease

Ahmedabad : Zydus Cadila on Wednesday announced that the Drug Controller General of India (DCGI) has approved its New Drug Application (NDA) for Saroglitazar Mg for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD) in India.

The prevalence of NAFLD in India is estimated to be nearly 25-30% of the general population. This approval for NAFLD along with either of the comorbidities (Obesity, Type 2 Diabetes Mellitus, Dyslipidemia or Metabolic Syndrome) provides the physicians with a viable treatment option. With a once daily, 4mg dose regimen, Saroglitazar Mg will enable better compliance, reduces the pill burden and offers the patient more convenience.

Non-Alcoholic Fatty Liver Disease (NAFLD) is a progressive disease of the liver, which starts with fat accumulation in the liver in patients who do not consume alcohol or take it in insignificant amounts, but have risk factors such as overweight or obesity, diabetes mellitus (high blood sugar), hypertension (high blood pressure) or dyslipidemia (abnormal blood lipids). This NAFLD condition could progress to NASH, cirrhosis and liver failure. It is a large unmet medical need as there is currently no approved drug for the treatment of NAFLD and NASH anywhere in the world.

“Zydus is committed to discovering novel medicines that can improve the quality of life of people. With Saroglitazar Mg, we have been able to successfully offer an innovative medicine for dealing with chronic liver diseases like NAFLD and NASH and helping patients in leading healthier lives” Mr. Pankaj Patel, Chairman, Zydus Group said.