Johnson & Johnson has won FDA approval for a new once-a-day HIV drug, adding to its growing portfolio of treatment options for the condition. Now J&J must find a way to distinguish the drug in an increasingly crowded market that includes Gilead Sciences’ hot-selling Biktarvy.

J&J’s Janssen drug unit announced that the FDA has approved Symtuza for adult HIV patients who are either treatment-naive or virologically suppressed on a stable antiretroviral regimen. Symtuza carries a black-box warning for post-treatment acute exacerbation of hepatitis B.

The drug is a combination of darunavir with a formulation which J&J says is designed for improved tolerability along with the convenience of a single dose. It is the first and only complete, darunavir-based single-tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.

J&J pointed out that HHS guidelines recommend darunavir-based therapies for treatment-naïve patients in certain clinical situations, including when a person may have uncertain adherence or when ARV treatment should be initiated before resistance test results are available.

"Many people living with HIV struggle to adhere to their medication, which can lead to the development of drug resistance and potentially cause their medication—or even an entire class of medications—to stop working," said Joseph Eron, M.D., a professor of medicine and director of the clinical core at the University of North Carolina Center for AIDS Research.

The difficulty for Symtuza is that it comes into the market on the heels of a number of other drugs that make adherence easier, including Juluca, the first HIV treatment regimen containing just two drugs, which J&J developed with GlaxoSmithKline. More importantly, it has to face Gilead’s Biktarvy.

Approved early this year, Biktarvy combines novel integrase inhibitor bictegravir with Gilead's Descovy, a combo of emtricitabine and tenofovir alafenamide. Descovy has already attained blockbuster status with $1.2 billion in 2017 sales, but analysts believe Biktarvy will do better, much better. They have pegged Biktarvy sales this year at $1 billion, with peak sales projected at $6 billion to $10 billion.

The FDA’s nod for Symtuza was based on data from two 48-week, noninferiority, pivotal phase 3 studies. The AMBER study looked at the safety and efficacy of Symtuza compared to a control regimen in adults, while the EMERALD study evaluated virologically suppressed adults. Both trials found the drug was effective and well-tolerated, with up to 95% of patients achieving or maintaining virologic suppression. The drug is already approved in Europe.

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