Strides Shasun Limited today announced that it has received approval for manufacturing generic version of sofosbuvir 400 mg (Gilead’s Sovaldi) from Drugs Controller General of India.
In September 2014, Strides entered into a licensing agreement with Gilead Sciences Inc to bring hepatitis C cure to 91 developing countries. The product will continue to be marketed under the brand name ‘Virso’ in India and overseas.
Sofosbuvir is the first-in-class NS5B polymerase inhibitor to be launched in India for hepatitis C treatment and represents a paradigm shift in the existing hepatitis C cure. The high potency, high barrier to resistance, pan genotypic activity, once-daily dosage, good safety profile and the limited drug-drug interactions of sofosbuvir makes it a breakthrough drug in hepatitis C treatment. This drug in combination therapy has shown to have high cure rates of around 90 per cent.
Globally, it is estimated that 170-185 million people (about 3 per cent of the world's population) are chronically infected with hepatitis C virus (HCV). 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.