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LONDON (Alliance News) - GlaxoSmithKline PLC Tuesday said its HIV venture with Pfizer Inc and Shionogi Ltd has submitted a regulatory application in the US for a single tablet HIV treatment that combines three separate drugs, and will submit an application for European approval in the near future.
ViiV Healthcare has submitted the application after the US Food and Drug Administration in August approved the use of dolutegravir, which goes by the brand name Tivicay, in combination with other antiretroviral agents for treating the HIV-1 form of the disease in adults and children over the age of 12 weighing at least 40 kilograms.
Dolutegravir is combined with abacavir and lamivudine in the new investigational single-tablet regimen that Viiv Healthcare has developed. It already sells a tablet combining just abacavir and lamivudine in the US and Europe under the brand name Epzicom in the US and Kivexa in the EU.
Clearance for the use of dolutegravir is currently being considered by they European Medicines Agency, and once that arrives, Viiv Healthcare will apply for marketing approval for the three drug tablet in Europe too.
Combination pills are increasingly being developed by HIV drug manufacturers as patients have been proven to stick with a single-pill treatments better than having to take the same drugs as separate pills.
"People living with HIV and their doctors seek to use appropriate treatment options for the individual, while also trying to minimise the number of pills required for effective and acceptable antiretroviral treatment," Dr John Pottage, chief medical officer of ViiV Healthcare said in a statement. "This submission aims to make a complete Tivicay-based regimen available for the first time in a single once-daily pill."
The US submission for the three drug pill is backed by data from one pivotal Phase III study and three other Phase III/IIIb studies which evaluated the safety and efficacy of the regimen. It also includes pivotal data evaluating the bioequivalence of the three drug pill compared with the administration of dolutegravir separately to the abacavir and lamivudine combination pill.
"A further 48-week Phase IIIb/IV study of this single-tablet regimen in treatment-naive HIV-positive women is ongoing," Viiv Healthcare said.
GlaxoSmithKline shares ended up 0.8% at 1,597.79 pence Tuesday.
By Steve McGrath; stevemcgrath@alliancenews.com; @stevemcgrath1
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