Wednesday, August 4, 2021

Zydus Cadila | NAFLD drug: Zydus Cadila receives DCGI nod for NAFLD drug Saroglitazar Mg in India


New Delhi: 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.

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.





Source link

Stay Connected

1,605FansLike
11,000FollowersFollow
342FollowersFollow
775FollowersFollow

Latest Articles

Need to create vigilance and awareness on zoonotic diseases: India’s Health Minister

The COVID-19 pandemic has highlighted the need of creating vigilance and awareness on zoonotic diseases, informed Union Health Minister Mansukh Mandaviya while virtually inaugurating...

Covid’s second wave proves lethal for pregnant women

At SVP Hospital in Ahmedabad – one of the major Covid-19 hospitals of the city – 148 pregnant women with Covid-19 infection were admitted...

7 Tips to Keep Your Gut Healthy

This is common to say health (and illness) starts in your gut. If you have poor gut health, you’ll experience anything from wrinkled skin, to...

SII making first batch of Covovax: Poonawalla

The first batch of Covovax, a Covid-19 vaccine developed by Novavax Inc, is being manufactured at the Serum Institute of India's Pune facility, SII...

Sputnik V is safest among all Covid-19 vaccines, no deaths recorded: Buenos Aires study

A study by the Buenos Aires Ministry of Health to monitor the safety of the Sputnik V vaccine against Covid-19 confirmed on Thursday that...