Thursday 10 December 2015

Home PUBLIC HEALTH Hetero’s ‘First Indian Company’ to Receive DCGI Nod to Treat Hepatitis C

Hetero’s ‘First Indian Company’ to Receive DCGI Nod to Treat Hepatitis C

Pharma Wisdom Jobs 08:17:00 PUBLIC HEALTH,

Hetero, one of India’s leading generic pharmaceutical companies and one of the world’s largest producer of anti-retroviral drugs, announced that it is the first company in India to receive the approval for the fixed-dose combination ledipasvir-sofosbuvir (90mg/400mg) from Drug Controller General of India (DCGI). Following the non-exclusive licensing agreement signed with Gilead Sciences in September last year, to manufacture and market chronic hepatitis C medicines, Hetero is all set to launch the fixed-dose combination therapy ‘ledipasvir-sofosbuvir’ for the Indian patients. The product will be available under the brand name ‘Ledisof’ in India.

Hetero is the first company in India to receive the approval for the fixed-dose combination Ledipasvir-Sofosbuvir (90mg/400mg) from Drug Controller General of India (DCGI), the company said in a statement.

The drug, Ledisof, is a generic version of Gilead Sciences’ brand Harvoni which is approved by the US FDA.

The Hyderabad based Hetero had singed a non-exclusive licensing agreement with Gilead in September last year to manufacture and market the drug indicated for the treatment of chronic hepatitis C and is the first company to receive DCGI approval for this category of drug.

Sofosbuvir in combination with ledipasvir has shown to have high cure rates of around 90 per cent.

Hepatitis C is a growing public health concern, particularly in developing countries. In India alone, it is estimated that 12-18 million patients are infected with hepatitis C which is several fold greater than those with HIV/AIDS.

Untreated chronic hepatitis C increases the risk of cirrhosis of liver, liver failure and hepatocellular carcinoma.

Dr. BPS Reddy, CMD, Hetero group of companies commented, “We have been the front-runners in launching the generic sofosbuvir in several countries. We are now happy to extend the fixed-dose combination therapy ‘ledipasvir-sofosbuvir (Ledisof) to Indian patients, which is much more effective than sofosbuvir. With the launch of Ledisof, we look forward in bringing a paradigm shift in hepatitis C management in the country.”