Who: Hetero Drugs
What: Received DGCI’s approval for hepatitis C drug
When: Announced on 8 December 2015
Hyderabad-based Hetero Drugs on 8 December 2015 announced that it received the approval of Drug Controller General of India (DCGI) to launch fixed-dose combination therapy Ledipasvir-Sofosbuvir. The product will be available under the brand name Ledisof in India.
With this approval, Hetero became the first company in the country to get approval from DGCI to launch hepatitis C medicines.
In September 2014, Hetero signed a non-exclusive licensing agreement with the USA-based Gilead Sciences in to manufacture and market chronic hepatitis C medicines.
This fixed-dose combination is the generic version of Gilead’s brand Harvoni. It was approved by US FDA for the treatment of chronic hepatitis genotype 1 in both treatment –naïve and treatment-experienced patients.
And, Sofosbuvir in combination with Ledipasvir has shown to have high cure rates of around 90 percentage.
About Hepatitis C
• It 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.