GlaxoSmithKline submits single-tablet, dual-drug HIV regimen for FDA approval
The makers of the first dual-therapy treatment to hold HIV at bay filed papers June 1 for approval from the U.S. Food & Drug Administration and the European Medicines Agency.
The treatment developed by GlaxoSmithKline and its subsidiary ViiV Healthcare would require only two drugs and would also be available in a single daily tablet.
ViiV’s CEO, Deborah Waterhouse, hailed the development as a boon for patients’ long-term convenience.
“At ViiV Healthcare, we are not only developing potential new medicines to treat and prevent HIV infection, we are challenging the traditional HIV treatment paradigm to develop new treatment regimens,” Waterhouse said in a press release. “We look forward to working with regulatory authorities to bring this new single tablet, two-drug regimen to appropriate people living with HIV.”
GlaxoSmithKline has paid $130 million to assure FDA review of dolutegravir and rilpivirine within six months, the release said.
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