The world’s first drug for the treatment of Non-Cirrhotic Non-Alcoholic Steato Hepatitis (NASH) has been approved in India.
The Drug Controller General of India (DCGI) has approved Ahmedabad-based Zydus Cadila’s New Drug Application (NDA) for Saroglitazar for treating NASH, a progressive disease of the liver.
“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,” said Pankaj Patel, Chairman of Zydus Group.
“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.
In January, the treatment received an approval for the treatment of Type 2 Diabetes Mellitus. In the last seven years, over a million patients have benefitted from this drug.
In a Phase 2 clinical trial, Saroglitazar demonstrated improvement in liver enzymes and lipids in patients with Non-Alcoholic Fatty Liver Disease (NAFLD).
On the global front, a Phase 2 trial in patients with NASH in the US met primary and secondary endpoints.
Additionally, 15 investigator initiated clinical studies of Saroglitazar have been presented and published in leading scientific journals and conferences.