Gilead tees up another hep C combo for FDA review

Gilead CSO Norbert Bischofberger

Gilead Sciences ($GILD), reaping billions from its duo of approved hepatitis C therapies, is moving toward the market with a third pill that promises to cure a wider range of patients with the virus.

The company submitted an FDA application for its fixed-dose combination of sofosbuvir, approved as Sovaldi, and an investigational NS5A inhibitor called velpatasvir. The combo, which received the agency's breakthrough therapy designation, has demonstrated stellar results in hep C genotypes 1 through 6, curing 98% of patients within 12 weeks across three Phase III trials.

If all goes according to plan, Gilead would be set to launch the sofosbuvir-velpatasvir combo some time next year, giving it three on-the-market hep C treatments to extend its dominance in the field.

Sovaldi, approved in 2013, marked a sea change in hep C by sparing patients the painful interferon regimens that had long been a cornerstone of treating the disease. Last year, Gilead did itself one better with the launch of Harvoni, a combination of sofosbuvir and ledipasvir that can cure genotype 1 hep C in as few as 8 weeks. Now, looking to add a pan-genotypic agent to that portfolio, Gilead is working to further increase its market share.

"Genotype 1 is the most prevalent form of HCV in the United States, but worldwide, more than half of people living with HCV are infected with other genotypes," Gilead Chief Scientific Officer Norbert Bischofberger said in a statement. "SOF/VEL complements our current HCV portfolio of Sovaldi and Harvoni, offering high cure rates and the potential to simplify treatment and eliminate the need for HCV genotype testing."

But while Gilead retains pole position in hep C, it's hardly alone in the space. It currently contends with AbbVie's ($ABBV) Viekira Pak, a combo treatment launched last year that is yet to significantly challenge Harvoni but, thanks to exclusive deals with payers, retains some market share. And waiting in the wings are Merck ($MRK) and Bristol-Myers Squibb ($BMY), companies at work on combo treatments of their own whose approval could put pricing pressure on Gilead.

- read the statement

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