Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection.
The twice-yearly treatment is indicated to be administered along with other antiretroviral(s) in adult patients with multi-drug resistant HIV infection who otherwise cannot have a suppressive anti-viral regimen.
The tablet formulation is intended for oral loading before administering the long-acting lenacapavir injection.
With the approval from the EC, the treatment will be made available in all 27 European Union member states as well as Liechtenstein, Norway and Iceland.
The company filed Marketing Authorization Application (MAA) for lenacapavir based on data from the Phase II/III CAPELLA clinical trial of lenacapavir plus an optimised background regimen in multi-drug resistant HIV patients who were heavily pre-treated.
According to the trial findings, an undetectable viral load (<50 copies/mL) was observed at week 52 in 83% of the subjects who received lenacapavir plus optimised background regimen.
Additionally, trial subjects had a mean rise in CD4 count of 83 cells/µL.
A long-acting HIV capsid inhibitor, lenacapavir has a multi-stage mechanism of action.
It is said to have no known cross-resistance to current drug classes, providing a new treatment option for HIV patients who are unresponsive to their existing therapy.
Gilead Sciences chairman and CEO Daniel O’Day said: “After more than three decades of driving advancements in HIV treatment and prevention, Gilead scientists have now delivered an innovative new option for long-acting care.
“Lenacapavir is a unique and potent medicine with the potential for flexible dosing options.
“Following today’s approval, it will now be the only twice-yearly treatment for people who struggle with multi-drug resistant HIV.
In July, the US Food and Drug Administration (FDA) accepted the New Drug Application resubmission of investigational lenacapavir for review.
A decision on the approval is anticipated by 27 December.
Earlier this month, the company entered a definitive agreement to acquire MiroBio for nearly $405m.