FDA approves first two-drug HIV regimen from GSK
NEW YORK: The U.S. Food and Drug Administration (FDA) on Tuesday approved the first two-drug regimen to treat HIV, the virus that causes AIDS, aimed at lessening the side effect burden of current treatments that combine three or four medicines.
The treatment, called Juluca, is a fixed-dose tablet that combines two previously approved drugs, dolutegravir, and rilpivirine, and is available to patients who have been on a stable regimen for at least six months.
Juluca belongs to GlaxoSmithKline Plc's majority-owned ViiV Healthcare, in which Pfizer Inc and Shionogi also have small stakes. ViiV's dolutegravir is part of GSK's traditional triple-therapy used to control HIV, while rilpivirine is a Johnson & Johnson drug.
The approval puts GSK ahead of rival Gilead Sciences in the race to market with two-drug combinations for HIV treatments, although uptake could be slow because rilpivirine has the downside that it must be taken with a meal at the same time every day.
The one-pill, once-a-day combination "provides people living with HIV the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen," John Pottage, ViiV's chief scientific officer, said in a statement.
The FDA has a February deadline to decide on Gilead's competing combination.
GSK is also working on a second two-drug combination that will replace rilpivirine with a common off-patent drug called 3TC that could reach the market in the second half of 2019 if clinical trials are successful.
Sales of GSK HIV medicines rose 26 percent to $4.25 billion in the first nine months of 2017.
(Reporting by Caroline Humer and Bill Berkrot in New York; Editing by Bernadette Baum and Matthew Lewis)