27th Jun 2014 12:00
LONDON (Alliance News) - GlaxoSmithKline PLC Friday said that its ViiV Healthcare Ltd joint venture with Pfizer Inc and Japan's Shionogi Ltd has received a positive opinion from a key committee of the European Medicines Agency for its investigational single tablet HIV treatment that combines three separate drugs.
A positive opinion from the committee is one of the final steps before marketing authorisation is granted by the European Commission, although it does not always result in marketing authorisation. Glaxo said it is expecting a final decision from the Commission in the third quarter of this year.
ViiV Healthcare submitted applications for the single tablet HIV treatment containing dolutegravir, which goes by the brand name Tivicay, in combination with abacavir and lamivudine, last October in both Europe and the US. 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.
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.
Glaxo shares were up 0.3% at 1,567.82 pence Friday.
By Steve McGrath; [email protected]; @stevemcgrath1
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