Gilead’s ($GILD) new combo of sofosbuvir and velpatasvir, which will be known as Epclusa, for hepatitis C has been given the backing of European regulators. It is now set to be approved within the next three months.
The cocktail treatment uses the single agent sofosbuvir--the ingredient in its first approved hep C drug Sovaldi--as well as its next-gen follow up Harvoni, where it was combined with ledipasvir. Both drugs went on the become multi-blockbusters, dominating the new hep C market and boasting massive cure rates compared to its rivals.
This new combination sees the first-time use of its investigational NS5A inhibitor velpatasvir and has together with sofosbuvir demonstrated stellar results in hep C genotypes 1 through 6, curing 98% of patients within 12 weeks across three Phase III trials.
Although Gilead is dominating the hep C space, there is still pressure from rivals AbbVie ($ABBV), Bristol-Myers Squibb ($BMY) and Merck ($MRK), with the increased demand for quicker, more effective drugs for the liver-destroying disease growing unabated.
Gilead is set to launch Epclusa in Europe and in all likelihood in the U.S. this year--giving it three on-the-market hep C treatments to extend its dominance in the field. It’s also gunning to treat all adults with all genotypes (1-6) with HCV.
The combo is under priority review with the FDA, which has set a PDUFA date of June 28 for its decision on whether to approve the med.
Across the pond, the CHMP recommendation will be sent to the European Commission, which should rubber stamp approval in the next three months.
- check out Gilead’s release