GlaxoSmithKline’s two-drug HIV bet just paid off.
Tuesday, the FDA approved Juluca, the first complete treatment regimen for the disease that contains just two drugs, versus the three or more included in rival cocktails. The antiviral, a fixed-dose tablet, combines dolutegravir—sold on its own as Tivicay—and rilpivirine, also known as Edurant, from Johnson & Johnson’s Janssen unit.
The approval may help give Glaxo a boost over chief rival Gilead Sciences in a couple key ways. First, “limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” Debra Birnkrant, director of the antivirals division of the FDA’s Center for Drug Evaluation and Research, said in a statement.
And it may also limit cost. GSK had not responded to a request for Juluca’s list price by press time.
The new competition isn’t exactly what Gilead wants, especially at a time when its hep C sales are in serious trouble. Earlier this year, it took another blow when Gilead’s bictegravir—a candidate in line to compete with Tivicay—didn’t prove superior to the Glaxo med.
That’s not to say the big biotech won’t continue giving Glaxo’s HIV unit, ViiV, a run for its money; it’s still chasing an approval for a three-med trifecta featuring bictegravir. And further down the line, Merck & Co. could stir up some trouble for both leading drugmakers with a candidate analysts say has potential as a twice-yearly injection.
In the meantime, though, the British drugmaker will welcome any market-share grab Juluca can come up with. Analysts aren’t so hot on GSK’s outlook for 2018, which includes continued pressures in the respiratory arena.