Drug Development

J&J lines up its 4-in-1 HIV pill for FDA behind rivals from Gilead, GSK

A couple of months after posting positive late-stage data for its quadruplet-in-one-pill for quelling HIV, J&J says it’s filed a marketing application with the FDA ahead of a planned marketing campaign.

Cocktail therapies have proven highly effective at keeping HIV at bay, but the big players in the market — like Gilead, GSK and J&J — 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.

In J&J’s case, researchers combined darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg (D/C/F/TAF) into a daily pill, with data from a pair of Phase III studies to prove that it’s non inferior to standard of care.

The big game in HIV R&D has been played between Gilead and GSK’s ViiV, which has also reported success on this front. A few weeks ago the FDA put Gilead’s application on the priority review track for its combination of bictegravir with its backbone HIV drugs emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) — Gilead had filed this application with a priority review voucher — after the treatment posted impressive efficacy results. Analysts have pegged peak sales in the billions, impressed by the convenience of a triple with a high rate of keeping the virus in check.

“This filing marks an important milestone in continuing to address the needs of individuals living with HIV who struggle with adherence and the associated risk of developing medication resistance,” said Richard Nettles, vice president, medical affairs, Janssen.


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