Lenacapavir, Gilead’s Long-Acting HIV Treatment, Approved in Europe

Today, Gilead Sciences, Inc. announced that the European Commission (EC) approved their Marketing Authorization Application (MAA) of lenacapavir to treat HIV infection. Lenacapavir will be marketed under the brand name Sunlenca and available in injection and tablet forms.

Lenacapavir was indicated in the EU for the treatment of multidrug-resistant HIV infection in adults. Lenacapavir will be administered among other HIV antiretrovirals to construct an adequately suppressive regimen.

“Lenacapavir helps to fill a critical unmet need for people with complex prior treatment histories and offers physicians a long-awaited twice-yearly option for these patients who are at greater risk of progressing to AIDS,” said Jean-Michel Molina, MD, a professor of infectious diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals.

Lenacapavir is a first-in-class capsid inhibitor and has no known cross-resistance to other existing drug classes. The MAA was approved after the reviewal of positive data from the phase 2/3 CAPELLA study (NCT04150068). The trial evaluated the safety and efficacy of lenacapavir in combination with an optimized background regimen in heavily treatment-experienced adults.

This patient population, with highly resistant HIV infection, represents a significant unmet medical need. Throughout the course of the CAPELLA study, 83% (30 of 36) participants receiving lenacapavir in conjunction with an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at week 52. The participants averaged a CD4 count of 83 cells/µL.

“In the CAPELLA study, lenacapavir, in combination with other antiretroviral therapies, demonstrated sustained rates of virologic suppression and clinically meaningful CD4+ T-cell recovery in people with multidrug-resistant HIV,” Molina explained. “Lenacapavir provides an innovative long-acting HIV therapy option with the potential to transform the clinical landscape.”

Gilead is still waiting for the US Food and Drug Administration (FDA) to make a regulatory decision after lenacapavir’s approval was delayed due to manufacturing issues. Lenacapavir had been stored in borosilicate vials, and due to vial compatibility problems, Gilead formulated a plan to store injectable lenacapavir in aluminosilicate glass instead.

In July, the FDA accepted Gilead’s New Drug Application (NDA) resubmission for investigational lenacapavir. Lenacapavir was assigned a Prescription Drug User Fee Act (PDUFA) date of December 27, 2022.

The European Marketing Authorization applies to all 27 states in the EU, as well as Norway, Iceland, and Liechtenstein. “Lenacapavir is a unique and potent medicine with the potential for flexible dosing options,” said Daniel O’Day, chairman and CEO of Gilead Sciences. Lenacapavir is designed to hinder HIV at multiple stages of its lifecycle, rather than just preventing viral replication. “Following today’s approval, it will now be the only twice-yearly treatment for people who struggle with multidrug-resistant HIV,” O’Day said.