Gilead seeks US approval for long-acting HIV drug lenacapavir

Gilead has filed its investigational long-acting HIV drug lenacapavir with the US Food and Drug Administration (FDA), seeking approval in patients with multi-drug resistant infection.

Lenacapavir is a HIV-1 capsid inhibitor in development for the treatment HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1.

The drug is designed to inhibit HIV-1 replication by interfering with a number of ‘essential’ steps in the viral lifecycle, including capsid-mediated uptake of HIV-1 proviral DNA, virus assembly and release and capsid core formation.

The FDA has already granted lenacapavir a breakthrough therapy designation for the treatment of HIV-1 infection in this patient population, as part of a combination regimen with other antiretroviral drugs.

In its submission, Gilead has included data from the Phase II/III CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with an optimised antiretroviral background regimen.

The study achieved its primary endpoint, with a significantly higher proportion of participants randomly allocated to receive lenacapavir achieving clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared to placebo.

Lenacapavir-treated patients also achieved statistically significantly greater mean decrease in viral load compared to placebo.

“Lenacapavir is an important breakthrough innovation with the potential to be transformative for people living with multi-drug resistant HIV who have very limited treatment options,” said Merdad Parsey, chief medical officer, Gilead Sciences.

“The filing moves us one step closer to providing an innovative treatment option that helps to address barriers to achieving viral suppression and meet the unmet needs of people living with multi-drug resistant HIV,” he added.

Gilead is also planning to submit marketing authorisation application for lenacapavir to the European Medicines Agency (EMA) in ‘the coming months’.