EC Approves Gilead Sciences’ Sunlenca for HIV

The European Commission (EC) has granted marketing authorization to Gilead Sciences’ Sunlenca (lenacapavir) injection and tablets, in combination with one or more antiretrovirals, for use in adult patients with multidrug-resistant human immunodeficiency virus (HIV) infection who can’t be treated with another antiviral regimen.

The marketing authorization was based on results from a phase 2/3 study in which 83 percent of participants taking the drug in addition to a background regimen achieved an undetectable viral load.

Earlier this year, the FDA declined to approve Gilead’s New Drug Application (NDA) for lenacapavir because of concerns about the proposed container vials. The agency later accepted a resubmitted NDA and set a decision date of Dec. 27.