India-based pharmaceutical firm Zydus Cadila said that its new drug application (NDA) for Saroglitazar has been approved by the Drug Controller General of India (DCGI) to treat non-cirrhotic non-alcoholic steatohepatitis (NASH) in India.
NASH, a progressive disease of the liver, commences with fat accumulation in the liver and may lead to cirrhosis and liver failure. Saroglitazar is claimed to be the world’s first drug for the treatment of non-cirrhotic NASH.
In September 2013, the company first launched Saroglitazar to treat diabetic dyslipidemia and hypertriglyceridemia in patients with type-2 diabetes not controlled by statins alone.
In January this year, the company secured approval for Saroglitazar to treat Type 2 Diabetes Mellitus.
With dual PPAR alpha and gamma properties, the Saroglitazar is effectively treating the comorbidities, including dyslipidemia, hypertriglyceridemia, diabetes mellitus.
Zydus reported positive data from the EVIDENCES II phase 3 liver biopsy trial of Saroglitazar 4mg versus placebo in Indian patients with NASH.
The study assessed histological improvement of NASH using liver biopsy at the end of 52 weeks and achieved primary and secondary endpoints.
According to the company, the Saroglitazar 4mg showed a significant reduction in liver fat, liver enzymes and disease activity.
Saroglitazar showed improvement in liver enzymes and lipids in patients with non-alcoholic fatty liver disease (NAFLD) in EVIDENCES I phase 2 clinical study.
Zydus Group chairman Pankaj Patel said: “We are happy that our efforts to discover and develop a novel drug for patients living with NASH, an unmet healthcare need globally have been successful.
“Saroglitazar will provide hope and new lease of life for millions of patients in India suffering from NASH.”
In December 2016, Zydus Cadila’s subsidiary Zydus Healthcare acquired six brands from MSD related to the women’s health, men’s health, cardiovascular and wound management areas for an undisclosed sum.
The brands bought by Zydus Healthcare in the deal are Deca-Durabolin, Durabolin, Sustanon, Multiload, Sicastat and Axeten which are expected to strengthen the global pharmaceutical group’s portfolio in key therapeutic sectors.