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June 14 (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, a fixed-dose once-daily tablet that combines two previously approved drugs, dolutegravir and rilpivirine, 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, which is aimed at lessening the side effects of current treatments that combine three or four medicines.
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.
However, a panel of the European Medicines Agency had in March recommended approval for the two-drug combination, which was approved by the U.S. Food and Drug Administration in November 2017.
The CHMP opinion sets the stage for a likely approval by the European Commission, which is expected towards the end of the second quarter of 2018, GSK said in March.
ViiV Healthcare said on Thursday it plans regulatory submissions for the two-drug combination later this year. (Reporting by Arathy S Nair in Bengaluru; editing by Alexander Smith and Jason Neely)