“Our efforts are focused on offering a safe and efficacious COVID-19 vaccine”

Zydus Cadila, an innovation-driven, global pharmaceutical company, has recently received the approval from the Drug Controller General of India (DCGI) for use of Saroglitazar in the treatment of type II diabetes mellitus as an add on therapy with Metformin. The drug was previously approved in the year 2013 for the treatment of hypertriglyceridemia and diabetic dyslipidemia in India. More than 1 million patients are being treated with Lipaglyn. BioSpectrum has spoken to Dr Sharvil Patel, Managing Director of Zydus Cadila about the future plans for the product and about the accelerated research programme launched for the development of the vaccine against coronavirus.

- Prapti Shah

Diabetes drug Saroglitzar is the world’s first drug for the treatment of Non-Cirrhotic NASH to be approved by DCGI. Your comments on that.

We are happy that our efforts to discover and develop a novel drug for patients living with nonalcoholic steatohepatitis (NASH), unmet healthcare need globally have been successful. Saroglitazar will provide hope and new lease of life for millions of patients in India suffering from non-alcoholic steatohepatitis, which is a progressive disease of the liver, which starts with fat accumulation in the liver known as Non-Alcoholic Fatty Liver Disease (NAFLD). This condition could progress to cirrhosis and liver failure. It is a large unmet medical need as there is currently no approved drug for the treatment of NASH anywhere in the world, a disease that is highly prevalent with 10 per cent to 30 per cent of the global population being affected by it. The prevalence of NASH in India is estimated to be nearly 25 per cent of the population and ranks as one of the major causes of cirrhosis, behind hepatitis C and alcoholic liver disease. Liver transplantation is the only option for managing advanced cirrhosis with liver failure. Saroglitazar is uniquely poised with its dual PPAR alpha and gamma properties – reducing the comorbidities (dyslipidemia, hypertriglyceridemia, diabetes mellitus) and causing NASH resolution. Zydus achieved positive results in EVIDENCES II trial, a phase 3 liver biopsy trial of Saroglitazar 4 mg versus placebo in Indian patients with NASH. The trial evaluated the histological improvement of NASH using liver biopsy at the end of 52 weeks and successfully met primary and secondary endpoints. Saroglitazar 4 mg demonstrated a significant reduction in liver fat, liver enzymes and disease activity.

What are your future plans for this drug?