- Johnson & Johnson's research unit Janssen Pharmaceuticals said Tuesday that U.S. regulators approved the once-daily medicine 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 — an oft-cited caution with HIV drugs.
- Symtuza's approval hinged on two Phase 3 trials. The first showed the drug was non-inferior to a combination of J&J's Prezista plus Gilead Sciences' Truvada in treatment-naive patients. The second assessed virologically-suppressed HIV patients taking Truvada plus a boosted protease inhibitor, and found there was little difference in virologic failure or suppression rates between those who stayed on that regimen and those who switched to Symtuza.
- Symtuza combines darunavir, an HIV-1 protease inhibitor; cobicistat, a CYP3A inhibitor; and two HIV-1 nucleoside analog reverse transcriptase inhibitors, emtricitabine and tenofovir alafenamide.
Though comprised of fairly common active ingredients across HIV medications, J&J highlighted how Symtuza is the first darunavir-based single-tablet regimen to gain approval for its two intended populations.
In a July 17 release, for instance, J&J noted that the U.S. Department of Health and Human Services recommends patients who have never taken HIV medication receive darunavir-based drugs in certain situations, such as when it's debatable whether they'll be adherent or when antiretroviral treatment is necessary before resistance tests read out.
"As clinicians, we may not always have the full picture of a patient's health or their risk for developing resistance when making treatment decisions," Joseph Eron, director of the University of North Carolina's Center for AIDS Research Clinical Core, said in the release.
He added that in late-stage testing "patients with more complex treatment histories or previous virologic failure, " responded positively to Symtuza, underscoring "its potential as an important new treatment option for a wide variety of patients."
While J&J rides high on its latest approval, there are still several hurdles ahead. One particularly daunting one will be securing market share. In the last year alone, the Food and Drug Administration has cleared a handful of HIV drugs, including GlaxoSmithKline and J&J's Juluca (dolutegravir/rilpivirine), Gilead's Biktarvy (bictegravir, emtricitabine & tenofovir alafenamide), and triplet and doublet regimens from Mylan.
Among the newer products, Biktarvy could be especially difficult to compete with. It locked down a broad label, approved for treatment-naive adult HIV patients, as well as those who have been virologically suppressed for at least three months on a stable antiretroviral regimen and haven't failed or shown resistance to the individual drugs that make up Gilead's drug. Additionally, patients don't need to take Biktarvy with food.
At the time of Biktarvy's approval, Jefferies analyst Michael Yee expected at least $850 million in 2018 sales and peak sales of $3 billion.
J&J's attention will surely turn to differentiating Symtuza from the pack. Fortunately for the big pharma, it doesn't rely too heavily on revenue from HIV drugs. Its most noteworthy product in the class is Edurant (rilpivirine), which brought in $211 million during the second quarter, or about 2% of J&J's pharmaceutical revenue.