REUTERS: GlaxoSmithKline said on Thursday that its two-drug treatment for HIV, the virus that causes AIDS, met its main goal in late stage studies: a big win after regulators warned of possible birth defects from one of the two drugs.
The safety results for the new HIV treatment, which combines dolutegravir and lamivudine, were consistent with the product labelling for the medicines, GSK's majority owned ViiV Healthcare said.
The studies were designed to evaluate the safety and efficacy of the two-drug combination.
U.S. and European regulators said in May they were assessing evidence that GSK's HIV drug dolutegravir might be linked to serious birth defects, casting a shadow over a medicine that has been a profit driver in recent years.
ViiV Healthcare said on Thursday it plans regulatory submissions for the two-drug combination later this year.
(Corrects drug to lamivudine not rilpivirine and removes reference to once-daily tablet in paragraph 2, removes incorrect reference to aim of the study in paragraph 3, deletes reference to European Medicines Agency approval)
(Reporting by Arathy S Nair in Bengaluru; editing by Alexander Smith and Jason Neely)