GSK, Pfizer partnership wins EU nod for HIV pill weeks after FDA approval

Hot on the heels of its FDA approval, a new combo pill from the HIV-focused partnership of GlaxoSmithKline ($GSK) and Pfizer ($PFE) has won approval in Europe. ViiV Healthcare said that the EU had given a green light to its once-daily combo pill Triumeq, an approval that will help it reach the $5 billion in peak sales it has been forecast to capture.

"Triumeq is a direct result of ViiV Healthcare's patient-centred approach to innovation," ViiV Healthcare CEO Dominique Limet said in a statement. "As a company that focuses 100% on HIV, our commitment is to continue to deliver new options for care and treatment for people living with HIV."

Triumeq is a triple play med, combining ViiV's first approved drug Tivicay (dolutegravir) with two generic treatments, abacavir and lamivudine. Approved last August, Tivicay was the third drug in a newer class of HIV fighters: integrase inhibitors.

ViiV was formed four years ago as a joint venture between GSK and Pfizer, which later added Japanese drugmaker Shionogi to the fold. The two approvals in the last year for ViiV have been a bright spot for GlaxoSmithKline CEO Andrew Witty, who otherwise has been defending against corruption charges in China and sinking revenues as generics have been eating into its best-selling drug Advair.

Drugmakers are putting premium prices on combo pills, pitching the ease of use and increased compliance as the reason. Triumeq will go up against Gilead Sciences' ($GILD) three-part cocktail Atripla and has some data to do well there. In a Phase III trial, Triumeq bested Gilead's drug with an 80% rate of virological suppression at 96 weeks compared to 72% for Atripla.

The success of these combo drugs is actually seen as putting a damper on the upside for the entire category of HIV drugs. According to EvaluatePharma, that market will grow from $17.5 billion in 2012 to $20.6 billion in 2016, when it will peak. It projects it will taper off to about $18 billion in 2018. The way EvaluatePharma sees it, some blockbuster drugs have made leaps in treating the disease and its attendant symptoms and the combos are making compliance more likely.

- here's the announcement

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