ViiV Healthcare, which operates its U.S. headquarters in RTP, won approval Wednesday from the FDA for its two-drug combination to treat HIV. It’s the first HIV treatment combining two drugs rather than three or more that the FDA has approved.

The approval could be big news for GlaxoSmithKline, which is the majority owner of ViiV, in the $27 billion a year HIV market. Rival Gilead has a new three-drug combination treatment under review by the FDA with a decision expected in early 2018.

The ViiV combination drug in one tablet is called Juluca, which the FDA described as “a complete treatment regimen.”

“The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care,” said ViiV CEO Deborah Waterhouse.

“This is the start of a new era in HIV treatment. We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”

A two-drug combo holds potential benefits for patients, the FDA noted.

“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Debra Birnkrant, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, in the announcement.

The FDA noted that Juluca is a fixed-dose tablet that contains two previously approved drugs (dolutegravir and rilpivirine). It was approved to treat adults with “HIV-1 whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.”

Confidence in two-drug combo

ViiV submitted the drug combo for FDA approval in June.

“Traditionally, we have used a regimen of three or more drugs to maintain HIV viral suppression, but to best serve people living with HIV we must always question the status quo. We believed that dolutegravir would have the right profile to be a core agent in a two-drug regimen,” said John Pottage, Jr, Chief Scientific and Medical Officer of ViiV Healthcare, when the drug combo was submitted for approval.

“Data from the [clinical trials] supported our hypothesis that a two-drug regimen of dolutegravir and rilpivirine could maintain viral suppression and these regulatory submissions mark what may be a step change in HIV treatment. We are grateful to the study participants and clinicians who have contributed so much to making these submissions possible.”

Approval came after two clinical trials of more than 1,000 people “whose virus was suppressed on their current anti-HIV drugs,” the FDA noted.

“Results showed Juluca was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs.”

Partnership with J&J

ViiV sells dolutegravir under the brand name Tivicay. A Johnson & Johnson unit sells rilpivirine as Edurant, according to tech news site SeekingAlpha, which first reported the FDA’s decision. The two companies agreed on joint research in 2014.

More than 1 million people are afflicted with HIV in the U.S., according to the FDA.

ViiV is a joint venture operated by GlaxoSmithKline, which is the majority owner, and Pfizer along with Japan-based Shionogi.

The firm employs some 700 people worldwide, including numerous researchers in RTP.