GlaxoSmithKline gets good news on two-drug AIDS treatment
Bengaluru — GlaxoSmithKline’s 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 on Thursday. 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. US 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 tw...
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