US regulators have approved the first two-drug regimen to treat HIV, in a boost for GlaxoSmithKline’s (LON:GSK) majority-owned ViiV Healthcare business. The approval marks good news for the blue-chip pharmco, giving it an edge over rival Gilead.
GSK’s share price has been little changed in London this morning, having lost 0.12 percent to 1,301.50p as of 09:46 GMT, underperforming the broader UK market, with the benchmark FTSE 100 index having climbed into positive territory and currently standing 0.26 percent higher at 7,430.57 points. The group’s shares have lost more than 13 percent of their value over the past year, and are down by just under 17 percent in the year-to-date.
HIV drug approval
GSK announced in a statement today that the US Food and Drug Administration (FDA) had approved ViiV Healthcare’s Juluca, indicated as a complete regimen for the maintenance treatment of HIV-1 infection. The treatment is the first two-drug regimen for the condition, and comprises dolutegravir and rilpivirine.
“This is the start of a new era in HIV treatment,” Deborah Waterhouse, CEO ViiV Healthcare commented in the statement. The company added that Juluca is the first medicine in its two-drug regimen pipeline. ViiV Healthcare has also submitted regulatory marketing applications in Europe, Canada, Australia and Switzerland.
Competition with Gilead
Reuters reported in its coverage of the news that the approval differentiates GSK from rival Gilead Sciences in the $27-billion-a-year HIV market, with the FDA due to decide on Gilead’s new hope in HIV, a three-drug combination, by February. The newswire notes that while the UK group hopes to rewrite treatment standards by delivering two-drug regimens which are just as effective as three-drug treatments but with fewer side effects, Gilead argues that the idea may risk resistance because the virus will only have to evade two rather than three drugs.