Zydus gets DCGI nod for Saroglitazar Mg for the treatment of non-alcoholic Fatty Liver Disease in India

New Delhi: Zydus Cadila has received approval from the Drug Controller General of India (DCGI) for 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.

Speaking about the development, Mr. Pankaj Patel, Chairman, Zydus Group said, “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.”

Saroglitazar Mg was launched in India in September 2013, for the treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with type-2 diabetes not controlled by statins alone. In January this year, Saroglitazar Mg received approval for the treatment of Type 2 Diabetes Mellitus.

In March 2020, Saroglitazar Mg had received approval for the treatment of NASH. In the last seven years, over one and half million patients have benefitted from this drug. Saroglitazar Mg is uniquely poised with its dual PPAR alpha and gamma properties – reducing the comorbidities (dyslipidemia, hypertriglyceridemia, and diabetes mellitus) and bringing about a NASH resolution.pr