GlaxoSmithKline JV wins FDA OK on HIV blockbuster dolutegravir – FierceBiotech

The FDA has stamped an OK on GlaxoSmithKline’s HIV drug dolutegravir–to be sold as Tivicay. The approval marks another key advance for Glaxo ($GSK) on the regulatory front this year, providing a blockbuster candidate that analysts believe should do very well in competing against Gilead’s ($GILD) rival therapies.

“HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a release. “The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA.”