Sliding into the HIV combo rivalry between Gilead and GSK, J&J has notched an approval for a 4-in-1 pill based on its antiretroviral med darunavir.
To be marketed as Symtuza, the drug is a single daily pill that combines J&J’s darunavir (800mg) with cobicistat (150 mg), emtricitabine (200 mg) and tenofovir alafenamide (10 mg) from Gilead. The latter two form the backbone combination for Gilead’s blockbuster triplet Biktarvy — with 2022 projected sales at $3.71 billion — while cobicistat is a pharmacokinetic enhancer.
While cocktail therapies have proven highly effective at keeping HIV at bay, the big players in the market have all been hustling along to prove that their combos can do the job while promising to improve adherence to drug regimens and heighten their consistency. Janssen, the J&J subsidiary behind the new treatment, believes that darunavir’s “high barrier to resistance” will also be key for clinicians.
Jefferies has pegged peak sales at $1 billion.
Symtuza was approved for both treatment-naïve patients and certain stably suppressed patients on antiretroviral therapy, though it was not recommended for patients with hepatitis B — similar to its status in Europe and Canada, where it got the green light in 2017 and earlier this year, respectively.
In two Phase III trials, the drug demonstrated non-inferiority against a control regimen, showing similar viral suppression rates and low virologic failure rates.
“There is more to be done in our fight to make HIV history, and we will not stop here,” said Brian Woodfall, Janssen’s global head of late development, infectious disease. “We will continue our efforts to advance treatment and remain steadfast in our pursuit of fulfilling the dream of a preventive HIV vaccine.”
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