The Economic Times; December 8, 2015. NEW DELHI: Drug maker Hetero has received approval from DCGI to market generic version of Gilead’s Harvoni, a drug used in the treatment of Hepatitis C, in the country. 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.
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 Indian patients, it added.
The product will be available under the brand name ‘Ledisof’.
“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 to bringing a paradigm shift in Hepatitis C management in the country”, Hetero group of companies CMD BPS Reddy said.
This fixed-dose combination is the generic version of Gilead’s brand Harvoni, approved by USFDA.
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.