GSK's two-drug HIV treatment meets main goal in later phase of study
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.
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 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 the 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.