Breakthrough hepatitis C therapy Epclusa (sofosbuvir and velpatasvir) from Gilead Sciences ($GILD) has been licensed to 11 Indian companies following its recent U.S. FDA approval, the Economic Times newspaper reports.
Citing an industry source, the Economic Times said the drug falls under a 2014 pact that led to Gilead issuing licenses to India-based manufacturers to make and/or market hep C treatments at sharply lower prices in around 100 developing countries, though excluding some countries such as China and Russia.
Though Epclusa was not approved at the time of the pact, it is expected that companies making and selling other licensed versions of Gilead products such as Sovaldi (sofosbuvir) would be able to make the newly approved therapy--a major advancement in treating patient types--as well.
The drug covers all genotypic treatment cases, eliminating the need for gene-type diagnostics, making it easier for doctors to prescribe for any patients who test positive for hepatitis C. The regimen is 1 pill a day for 8-12 weeks.
"This forward thinking strategy opened for these Indian companies the market across all of India for generic versions of these drugs, plus the market for 100 other countries," an industry source told the Economic Times.
A spokesman for Gilead was not immediately available for comment.
- here's the story from the Economic Times
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