GSK and ViiV score breakthrough therapy designation in HIV prevention, as Truvada showdown draws nearer
A little less than a week after beefing up the data package it plans to take to the FDA for the experimental HIV drug cabotegravir, GSK-owned ViiV Healthcare has received good news on the medicine’s prospects.
Regulators designated cabotegravir as a breakthrough therapy for preventative HIV treatment, the company announced Tuesday afternoon, setting up a showdown with Gilead’s Truvada. ViiV R&D chief Kimberly Smith said it likely sets up an NDA submission in the first half of next year, with the hope of launching the drug in early 2022.
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