Zydus Cadila, a global pharmaceutical company has recently announced that the Drug Controller General of India (DCGI) has approved its New Drug Application for their Saroglitazar.
Saroglitazar is a drug that is used for the treatment of Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH) in patients.
Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH) is caused by the accumulation of fat in the liver and can potentially progress to cirrhosis and liver failure, which can only be treated by liver transplants.
NASH is a huge unmet medical need as 10% – 30% of the total global population is being affected by this disease. And also, currently there are no approved drug in the world that treats it.
This disease is ranked as one of the major causes of cirrhosis, behind hepatitis C and alcoholic liver disease.
Chairman of Zydus Group says that they are excited that their efforts to discover and develop a novel drug for patients living with NASH have been successful, providing hope for millions of patients suffering from the disease.
Saroglitazar was launched in India back in September of 2013 for the treatment of Diabetic Dyslipidemia and Hypertriglyceridemia in patients with Type 2 Diabetes not controlled by statins alone.
This year, they received approval for the treatment of Type 2 Diabetes Mellitus.
The drug is expected to enter the Indian market in the next three months and subsequently in Mexico after.
NASH is estimated to have affected nearly 25% of the total population in India.