Isentress Approval Carries Limited Indication
This article was originally published in The Pink Sheet Daily
FDA follows lead of its September Antiviral Drugs Advisory Committee recommendation.
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The launch of Tivicay, a once-daily integrase inhibitor, will be the driving force behind the HIV specialist’s return to growth, anticipated in 2014, according to CEO Dominique Limet.
The HIV specialist, a joint venture between GSK, Pfizer and Shionogi, will launch the once-daily integrase inhibitor Tivicay, priced slightly higher than Merck’s Isentress and about on par with Gilead’s Stribild when Tivicay is combined with backbone therapy.
Industry/government/academia collaboration would produce a new portfolio of drugs to eradicate the virus from tissue reservoirs where it lies latent, providing possible drug-free remission and potentially a cure: