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New Gilead hep C combo Epclusa gains FDA approval

New medication approved by the FDA to treat 6 types of hepatitis C.

Gilead ($GILD) has seen its new combo of sofosbuvir and velpatasvir gain FDA approval as the company now offers a new cocktail that can treat all 6 types of hep C.

The cocktail treatment, now known as Epclusa, 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. It can also cater for the hard-to-treat genotype 3 patients.

This new combination, which also sees its used with the older injectable drug ribavirin in advanced patients, 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.

But Gilead will hope to outrun its rivals as it’s the first to treat all adults with all genotypes (1-6) with HCV. The drug was also given the thumbs up by European regulators earlier this year.

Read Full Article: New Gilead hep C combo Epclusa gains FDA approval | FierceBiotech

Read Full Article: New Gilead hep C combo Epclusa gains FDA approval | FierceBiotech

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