The Drug Controller General of India (DCGI) has approved Zydus Cadila’s new drug application (NDA) for Saroglitazar for treatment of Non-Cirrhotic, Non-Alcoholic SteatoHepatitis (NASH) in India, making it the first-ever drug in the world for treatment of the disease.
NASH is a progressive disease of the liver, which starts with fat accumulation in the liver known as Non-Alcoholic Fatty Liver Disease (NAFLD), leading to cirrhosis and liver failure.
Sharvil P. Patel, managing director, Zydus Cadila, said “There are 50 to 70 million NASH patients globally. So, the global market size will be around $30 billion to $45 billion. India accounts for one of the highest for NASH cases. Our new drug will be available in India in the next three months and will stop deterioration of liver for NASH patients. This drug will become our largest brand.”
This is a large unmet medical need as there is currently no approved drug anywhere in the world for the treatment of NASH, a disease that is highly prevalent, with 10% to 30% of the global population being affected by it. The prevalence of NASH in India is estimated to be among nearly 25% of the population.
NASH 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.
Pankaj Patel, chairman, Zydus Group, 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.”
Saroglitazar 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.
When asked about COVID-19, Mr. Patel said, “For coronavirus, we are developing a vaccine as well as a diagnostic set. We are also working on a drug for coronavirus.”
