Gilead lines up for a fast FDA OK with its next-gen hep C combo

Gilead CEO John Martin

Gilead Sciences ($GILD), already dominating the market for hepatitis C cures, is nearing FDA approval for a new combination therapy that promises to treat a wider range of patients than the company's two approved products.

The latest treatment combines sofosbuvir, approved as Sovaldi in 2013, and an investigational NS5A inhibitor called velpatasvir. The FDA enrolled Gilead's cocktail into its priority review program, shorting the standard vetting time by about four months and promising to hand down a final decision by June 28.

Across three Phase III trials, a daily dose of Sovaldi and velpatasvir charted a 98% 12-week cure rate among patients with hep C genotypes 1 through 6, Gilead said. If approved, the fixed-dose pill could expand the company's multibillion-dollar hep C franchise and help it fend off mounting competition from rivals pushing similar products toward the market.

Sovaldi's approval marked a sea change in hep C as the first agent that could spare patients the painful regimens of interferon long required to treat the disease. In 2014, Gilead further altered the landscape with Harvoni, a combination of Sovaldi and ledipasvir that can cure genotype 1 hep C, the most common strain of the virus, in as few as 8 weeks. The launch of a pan-genotypic cure could extend Gilead's lead in the field and potential eliminate the need for genotype testing in hep C, the company has said.

But Gilead's place at the top is hardly assured as the company contends with a rival hep C cocktail from AbbVie ($ABBV), which is also developing next-generation combinations with eyes on faster cures for more patients. And waiting in the wings are Merck ($MRK) and Bristol-Myers Squibb ($BMY), companies developing treatments whose eventual approvals could put pricing pressure on Gilead.

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