Gilead Gets CHMP Backing for Lenacapavir in Multi-Drug Resistant HIV

By Colin Kellaher

Gilead Sciences Inc. on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of its investigational drug lenacapavir for people with multi-drug-resistant HIV.

The recommendation covers lenacapavir for the treatment of HIV-1 infection, in combination with other antiretrovirals, in adults with multi-drug resistant HIV-1 infection for whom it otherwise isn't possible to construct a suppressive anti-viral regimen, the Foster City, Calif., biopharmaceutical company said.

It expects a final decision from the European Commission, which generally follows the CHMP's advice, later this year.

The U.S. Food and Drug Administration earlier this year rejected Gilead's application seeking approval of lenacapavir due to issues related to the vials in which the drug is stored. Gilead recently said it has identified an alternative vial for lenacapavir.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

06-24-22 0848ET