HIV drug by GSK given priority status in US
US regulators have given priority review status to an experimental GlaxoSmithKline drug for HIV-Aids, which industry analysts view as a possible multibillion-dollar-a-year seller.
The US Food and Drug Administration is due to give its verdict on approving dolutegravir by August 17th, Britain’s biggest drugmaker said yesterday.
The once-daily drug is owned by ViiV Healthcare, a joint venture focused on HIV in which GSK is the largest shareholder.
The drug has performed well in clinical trials, prompting GSK to redraw a deal with Japan’s Shionogi. Under that agreement, Shionogi took a 10 per cent stake in ViiV – which was set up in 2009 between GSK and Pfizer – in exchange for its shared rights to dolutegravir.
The agreement left GSK with 76.5 per cent of ViiV, Pfizer controlling 13.5 per cent and Shionogi the remainder. – (Reuters)