- The U.S. FDA on Monday okayed Gilead's HIV combo drug Descovy, the third therapy using a new form of tenofovir to make it to market in the U.S.
- Descovy follows the approvals of Gilead's Genvoya and Odefsey, all three of which are indicated for the treatment of HIV-1 and carry a boxed warning about possible buildup of lactic acid in the blood, as well as severe liver problems.
- The three drugs are successors to Gilead's current HIV franchise and rely on a compound known as tenofovir alafenamide (TAF), more potent and efficient than the previously used tenofovir disoproxil.
Descovy also passed muster in the E.U., where the European Medicines Agency gave the drug a green light in late February.
"With today’s approval, Gilead is now able to offer patients and providers in the United States a range of options from our TAF based-portfolio, which is designed to help address the diverse needs of HIV patients worldwide," said Norbet Bischofberger, Chief Scientific Officer at Gilead.
Gilead currently has five drugs on the market in the U.S. and the E.U. which use the older TDF. Taken together, they earned nearly $3 billion in the fourth quarter of last year. In clinical studies, TAF has shown similar efficacy to TDF but at roughly 1/10th the dosage.
The new version also has a better safety profile with better renal and bone density outcomes through 48 weeks in a phase 3 study. TAF can enter HIV-infected cells more efficiently, leading to 90% less tenofovir in the bloodstream.
Higher efficacy has buoyed hopes for the outlook of Gilead's new TAF-based drugs. Descovy combines TAF with another compound, emtricitabine, and is taken in a single tablet.
Gilead has been criticized for its introduction of TAF, however. The AIDS Healthcare Foundation claims the company deliberately delayed bringing TAF to market in order to maximize the patent life of its HIV franchise.