Hetero receives DCG(I) approval for fixed-dose combination therapy ‘Ledipasvir-Sofosbuvir’

The product will be available under the brand name ‘Ledisof’ in India

Hetero has received the approval for fixed-dose combination Ledipasvir-Sofosbuvir (90mg/400mg) from Drug Controller General (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.

This fixed-dose combination is the generic version of Gilead’s brand Harvoni, approved by the US FDA for the treatment of chronic hepatitis genotype 1 in both treatment –naïve and treatment-experienced patients. 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, Chairman and Managing Director, 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.”