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Zydus Cadila receives DCGI nod for NAFLD drug in India

The Drug Controller General of India (DCGI) has approved the new drug application (NDA) for Saroglitazar Mg for the treatment of non-alcoholic fatty liver disease (NAFLD) in India, Zydus Cadila said in a regulatory filing.

December 30, 2020 / 11:43 AM IST
Aarti Drugs Ltd.

Aarti Drugs Ltd.

Drug firm Zydus Cadila on Wednesday said it 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.

The Drug Controller General of India (DCGI) has approved the new drug application (NDA) for Saroglitazar Mg for the treatment of non-alcoholic fatty liver disease (NAFLD) in India, Zydus Cadila said in a regulatory filing.

Zydus Cadila said the prevalence of NAFLD in India is estimated to be nearly 25-30 per cent of the general population.

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.

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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, the 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 an approval for the treatment of Type 2 Diabetes Mellitus. In March 2020, Saroglitazar Mg had received approval for the treatment of NASH.
PTI
first published: Dec 30, 2020 11:43 am

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