ViiV Healthcare says FDA has approved its two-drug HIV regimen, in first such instance
ViiV Healthcare, which is majority-owned by GlaxoSmithKline and has Pfizer Inc. and Shionogi as shareholders, said on Tuesday that the Food and Drug Administration has approved its two-drug HIV regimen. The therapy, Juluca, is the first such HIV drug composed of just two drugs -- dolutegravir and rilpivirine, both of which have been previously approved -- while other HIV regimens are typically composed of at least three drugs. This advancement could make the regimen more tolerable for the patient, according to Dr. Debra Birnkrant, director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research. Juluca is approved for individuals with HIV-1 who have been stable on a regimen for at least half a year, have no history of treatment failure and no known resistance to Juluca's individual components, ViiV said. GlaxoSmithKline shares declined 0.8% in Tuesday trade; shares have dropped nearly 10% over the last three months, compared with a 7% rise in the S&P 500 and a nearly 8% rise in the Dow Jones Industrial Average .
Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.