Zydus Cadila receives DCGI nod for Saroglitazar Mg
Saroglitazar Mg is used for the treatment of non-alcoholic fatty liver disease
Zydus Cadila has received approval from the Drug Controller General of India (DCGI) for Saroglitazar Mg, used for the treatment of non-alcoholic fatty liver disease (NAFLD), in the country.
Zydus Cadila said the prevalence of NAFLD in India is estimated to be nearly 25-30 per cent of the general population.
NAFLD is a progressive disease of the liver. It starts with fat accumulation in the liver of non-alcoholic patients who are overweight, have diabetes mellitus (high blood sugar), hypertension (high blood pressure) or dyslipidemia (abnormal blood lipids).
The condition can 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 Cadila said.
Pankaj Patel, Chairman of Zydus Group, said, “With Saroglitazar Mg, the company has 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.