It cost $130 million, but GSK’s ViiV carved a short path to an FDA approval of its two-drug HIV combo, widely tapped for blockbuster status as Gilead winds up for a likely OK of its rival triple therapy in February.
GSK has been a leader in HIV research, with Gilead, where the focus has been on looking for the simplest approach to safely keeping HIV under medical lock and key in the patient as researchers search for a new way to root it out of cells altogether. Regulators clearly like the way this two-drug, fixed dose combination of dolutegravir and rilpivirine (from J&J) can work on patients’ behalf, replacing other cocktails that require three or more drugs.
“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Debra Birnkrant, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.
That’s a recipe for success, in most analysts’ eyes, that could easily be worth billions in annual revenue. This new drug will be sold as Juluca.
Not to be outdone, the aggressive players at Gilead expect to quickly field their triple the mixes bictegravir with their backbone HIV drugs emtricitabine/tenofovir alafenamide. That approach proved equal to dolutegravir and other antiretroviral drugs, setting up expectations that Gilead can reap a megablockbuster reward, which it needs to maintain its lead role in HIV as the hep C franchise withers.
EvaluatePharma has pegged 2022 sales of the Gilead triple at $4.4 billion while GSK is expected to rake in $5.4 billion at the same time with its combo. That qualifies this approval, with a shortened pathway cleared by its purchase of a priority review voucher for $130 million, as a key win for new CEO Emma Walmsley, who also celebrated the recent approval of their shingles vaccines Shingrix.
Now the focus is on kickstarting some more interesting work at their pharma group, which has been a disappointment for years.
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