Therapy Areas: AIDS & HIV
Gilead Receives First Global Regulatory Approval of Sunlenca as Twice-Yearly HIV Treatment Option
23 August 2022 - - The European Commission has granted Marketing Authorization for Sunlenca (lenacapavir) injection and tablets for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen, US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) said.

Lenacapavir is a first-in-class capsid inhibitor with a multi-stage mechanism of action and has no known cross resistance to other existing drug classes, offering a new, every six-month treatment option for people with HIV whose virus no longer effectively responds to their current therapy.

The Marketing Authorization Application for lenacapavir is supported by data from the Phase 2/3 CAPELLA study, which evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV who are heavily treatment-experienced.

In this patient population with significant unmet medical need, 83% (n=30/36) of participants receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (


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