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Review
. 2022 Sep;82(14):1499-1504.
doi: 10.1007/s40265-022-01786-0.

Lenacapavir: First Approval

Julia Paik  1
Affiliations
Review

Lenacapavir: First Approval

Julia Paik. Drugs. 2022 Sep.

Erratum in

Abstract

Lenacapavir (Sunlenca®) is a long-acting capsid inhibitor of human immunodeficiency virus type 1 (HIV-1) being developed by Gilead Sciences Inc. It is available as an oral tablet and injectable solution, with the latter being a slow-release formulation to allow bi-annual subcutaneous administration. In August 2022, lenacapavir received its first approval in the EU for use 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. This article summarizes the milestones in the development of lenacapavir leading to this first approval for the treatment of HIV-1 infection.

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Conflict of interest statement

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Julia Paik is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Figures

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Key milestones in the development of lenacapavir for the treatment of HIV-1 infections. EMA European Medicines Agency, FDA Food and Drug Administration, MAA Marketing Authorization Application, NDA New Drug Application, PDUFA Prescription Drug User Fee Act
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Chemical structure of lenacapavir
See this image and copyright information in PMC

References

    1. Teeraananchai S, Chaivooth S, Kerr SJ, et al. Life expectancy after initiation of combination antiretroviral therapy in Thailand. Antivir Ther. 2017;22(5):393–402. doi: 10.3851/IMP3121. - DOI - PubMed
    1. Oh KS, Han E. A comparison of medication adherence and viral suppression in antiretroviral treatment-naive patients with HIV/AIDS depending on the drug formulary. PLoS ONE. 2021;16(1):e0245185. doi: 10.1371/journal.pone.0245185. - DOI - PMC - PubMed
    1. Shubber Z, Mills EJ, Nachega JB, et al. Patient-reported barriers to adherence to antiretroviral therapy: a systematic review and meta-analysis. PLoS Med. 2016;13(11):e1002183. doi: 10.1371/journal.pmed.1002183. - DOI - PMC - PubMed
    1. Gilead Sciences Inc. Lenacapavir (Sunlenca®): EU summary of product characteristics. 2022. https://ema.europa.eu/. Accessed 21 Sep 2022.
    1. Gilead Sciences Inc. Gilead announces first regulatory approval for Sunlenca® (lenacapavir), the only twice-yearly HIV treatment option [media release]. 22 Aug 2022. https://www.gilead.com/.