Gilead wins speedy FDA review for latest hep C combo

Gilead Sciences ($GILD) already reaps billions from its hep C meds Sovaldi and Harvoni, but the company isn't content to sit back with the status quo. It's prepping a new hep C combo for FDA approval and recently got a boost after the agency granted the med a speedy review.

The FDA gave its priority review designation to Gilead's new combo pill, which includes Sovaldi and investigational compound velpatasvir (VEL) and treats genotypes 1-6 of the virus. The regulatory move comes months after Gilead submitted its application for the combo med, also known as SOF/VEL, to the agency, citing results from Phase III trials which showed that the med cured 98% of patients within 12 weeks across three studies.

"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 CSO Norbert Bischofberger said last year. "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."

If all goes swimmingly, the FDA will make its final decision on Gilead's new hep C combo by June 28, 2016, the company said in a statement.

Approval for a new hep C combo would help boost Gilead's market share and give it even more of a lead over its rivals. Sovaldi and Harvoni face competition from AbbVie's ($ABBV) Viekira Pak, which grabbed more market share last year after AbbVie inked exclusive deals with payers for the med. Gilead bounced back with a few deals of its own to preserve its top-dog status.

Gilead CSO Norbert Bischofberger

And Foster City, CA-based Gilead is still working hard to retain its lead, snagging FDA approval in November for new indications for Harvoni in patients with certain subtypes of hep C. "Harvoni … continues to demonstrate high cure rates and a tolerable side effect profile across a range of patient populations, including those who have historically been considered among the most difficult to cure," Bischofberger said at the time.

But Bristol-Myers Squibb ($BMY) and Merck ($MRK) are also hard at work on hep C combo treatments, which could put more pressure on Gilead in the future. Merck, for one, plans on carving out its own path.

Adam Schechter, Merck's president of global human health, said that the company has "a competitive profile to be able to be successful in the marketplace." Merck knows "the players, and we know the managed care organizations very, very well," Schechter said last year, potentially giving the company an advantage as it builds on its strategy of tapping hep C niches and smaller patient pools to gain momentum for its hep C combo.

- here's Gilead's statement

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