(Alliance News) - GlaxoSmithKline PLC investee ViiV Healthcare on Tuesday said US health regulators have kicked off rolling review of its Cabotegravir HIV prevention drug.
The rolling submission for a new drug application allows ViiV to submit portions of data for regulatory approval from the US Food & Drug Administration. It means ViiV does not have to wait until all data is ready for submission.
Cabotegravir is a HIV pre-exposure prophylaxis, or PrEP, drug. ViiV said submission of the drug will be based on results from two phase IIb/III trials.
"With today's announcement we're one step closer to being able to provide the first, long-acting,
therapy to prevent HIV," ViiV Head of Research & Development Kimberly Smith said.
ViiV is majority-owned by GSK, with Pfizer Inc and Shionogi Ltd also owning stakes.
GSK shares were 0.2% lower at 1,337.26 pence each in London on Tuesday afternoon.
By Eric Cunha; ericcunha@alliancenews.com
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