GlaxoSmithKline turns up the heat on Gilead with landmark 2-drug HIV win

GlaxoSmithKline is hoping to steal market share from chief HIV rival Gilead Sciences.

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.

RELATED: Glaxo's two-drug HIV bet looks good in phase 3 studies—and turns up the heat on Gilead

Virtual Roundtable

ESMO Post Show: Highlights from the Virtual Conference

Cancer experts and pharma execs will break down the headline-making data from ESMO, sharing their insights and analysis around the conference’s most closely watched studies. This discussion will examine how groundbreaking research unveiled over the weekend will change clinical practice and prime drugs for key new indications, and panelists will fill you in on the need-to-know takeaways from oncology’s hottest fields. Register today.

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.

RELATED: GSK investors cheer as Gilead's HIV candidate bictegravir fails to beat their own Tivicay

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.

Suggested Articles

Last year at ESMO, AZ and Merck showed Lynparza topped its rivals at fending off prostate cancer. Now, Lynparza has helped patients live longer, too.

Merck and Eisai are trying to take their Keytruda-Lenvima combo into additional cancers, and new data provide a glimpse of where it might go next.

Bristol-Myers already has one Opdivo combo approved in kidney cancer, but it’s going for another—and new trial data could be just the ticket.