Drug Development

Gilead circles February 12 on its calendar as D-day for its HIV franchise

John Milligan, Gilead CEO

It won’t be long now before Gilead gets an official answer on its marketing application for a new HIV triple with megablockbuster potential.

The FDA has put this 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.

The decision date on this is now February 12. That’s a couple months behind Geoffrey Porges’ earlier expectations on the timeline.

Just days ago Gilead detailed the data from two Phase III studies demonstrating a match with GSK’s dolutegravir and other antiretroviral drugs in a full slate of late-stage studies.

Analysts have pegged peak sales in the billions, impressed by the convenience of a triple with a high rate of keeping the lethal virus in check. the therapy is central to Gilead’s efforts to protect its multibillion-dollar HIV franchise as hep C revenue fluctuates ahead of an expected spiral. Its chief rival is GlaxoSmithKline’s ViiV, which has also been effective in fielding new therapies that have captured market share.

Gilead bought Sarepta’s PRV earlier this year for $125 million.

The EMA also has the triple under review.


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RAPS Regulatory Convergence 2017