GlaxoSmithKline's ViiV wins FDA nod for three-in-one HIV treatment

ViiV Healthcare, the HIV-focused venture majority-owned by GlaxoSmithKline ($GSK), picked up FDA approval for a single pill that combines three antivirals and promises to challenge a leading treatment from Gilead Sciences ($GILD).

The drug, to be marketed as Triumeq, combines abacavir and lamivudine, compounds designed to stop HIV from replicating itself, with dolutegravir, which blocks an enzyme that allows the virus to crack its host's DNA. Each of the components is already FDA-approved in its own right, but ViiV--owned by GSK, Pfizer ($PFE) and Japan's Shionogi--believes an all-in-one pill can simplify treatment and potentially boost patient adherence.

In the combo's Phase III program, it successfully beat out Gilead's three-part cocktail Atripla, charting a statistically significant 80% rate of virological suppression at 96 weeks compared to 72% for its comparator. Gilead's drug combines the antivirals emtricitabine, tenofovir and efavirenz, and it leads the market among fixed-dose treatments, bringing in $3.6 billion for the company in 2013.

Viiv CEO Dominique Limet

"Today's approval of Triumeq offers many people living with HIV in the U.S. the first single-pill regimen containing dolutegravir," CEO Dominique Limet said in a statement. "ViiV Healthcare is committed to delivering advances in care and new treatment options to physicians and people living with HIV."

The approval is ViiV's second since its formation in 2009, following last year's nod for dolutegravir as a monotherapy, marketed as Tivicay.

Analysts have pegged that drug's peak potential at nearly $5 billion a year, but ViiV's next project could be its most promising. In June, the company struck up its first external partnership, teaming up with Johnson & Johnson ($JNJ) to pair dolutegravir with that company's rilpivirine (Edurant), which can halt viral replication without the toxicity risks inherent in older treatments like emtricitabine and abacavir.

- read the statement