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U.S. regulators gave priority review
status to an experimental GlaxoSmithKline drug for HIV/AIDS, which industry
analysts view as a possible multibillion-dollar-a-year seller.
The U.S. Food and Drug
Administration awards certain drugs priority status when they have the
potential to offer significant improvement over existing treatments.
The agency is due to give its
verdict on whether to approve dolutegravir by August 17, Britain's biggest
drugmaker said on Friday.
The once-daily drug, which belongs
to a novel class known as integrase inhibitors that block the virus causing
AIDS from entering cells, is owned by ViiV Healthcare, a joint venture focused
on HIV in which GSK is the largest shareholder.
The new medicine has already
performed strongly in clinical trials, prompting GSK to raise its bet on the
product last October by redrawing a deal with Japan's Shionogi.
Under that agreement Shionogi agreed
to take a 10 percent 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 holding 76.5
percent of ViiV, with Pfizer controlling 13.5 percent and Shionogi the
remainder.
Analysts see dolutegravir as a
strong competitor to HIV treatments from market leader Gilead Sciences.
The FDA is scheduled to issue a
decision on the drug’s approval by August 17.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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