Gilead wins FDA approval for a new HIV combo pill with rivals at its heels

Gilead Sciences ($GILD) won FDA approval for another combination tablet designed to keep HIV from replicating itself, a drug the company touts as a safer alternative to products already on the market.

The pill, Genvoya, combines emtricitabine, approved as Emtriva; cobicistat, cleared as Tybost; elvitegravir, on the market as Vitekta; and the investigational tenofovir alafenamide, which is a souped-up version of the active ingredient in the company's Viread. Genvoya is approved for patients with HIV genotype 1 who have either never taken an antiviral or whose virus is already suppressed.

In two Phase III trials disclosed last month, Genvoya proved itself equal to Gilead's four-drug cocktail Stribild while posting a significantly superior safety profile, the company said. The new combo is contraindicated for patients with severe kidney impairments, the FDA said, and it carries a black-box warning over risks of lactic acid buildups and liver problems.

Genvoya is the latest success among Gilead's pipeline of mix-and-match HIV cocktails, and it marks the first approval for tenofovir alafenamide, or TAF, which is the cornerstone of the company's future in treating the virus. Gilead paid $125 million for an FDA priority review voucher to accelerate the path of a pill combining TAF with Emtriva and Johnson & Johnson's ($JNJ) rilpivirine, approved as Edurant. And the company is also awaiting approval for a fixed-dose combo of TAF and Emtriva alone.

Meanwhile, Gilead is facing mounting competition from partner J&J and the joint venture ViiV Healthcare, which is owned by GlaxoSmithKline ($GSK), Pfizer ($PFE) and Shionogi. Each is at work on combination therapies designed to tamp down HIV with fewer safety risks, angling for dominance in a multibillion-dollar market.

ViiV presents perhaps the biggest challenge to Gilead, cutting into the company's market share with a combo of its own called Triumeq. And ViiV and J&J are at work on a combination of the former's cabotegravir and latter's Edurant that promises to replicate the effect of daily oral medication with an injection every four to 8 weeks. That therapy is slated to enter Phase III next year, and ViiV and J&J hope to win approval by 2020.

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