Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher; Bixlenvo (Bictegravir and Lenacapavir)

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material threat MCM priority review voucher. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the issuance of material threat MCM priority review vouchers as well as the approval of products redeeming a voucher. FDA has determined that Bixlenvo (bictegravir and lenacapavir), tablets, approved August 27, 2026, meet the redemption criteria.

Full Text

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<title>Federal Register, Volume 91 Issue 207 (Wednesday, October 28, 2026)</title>
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[Federal Register Volume 91, Number 207 (Wednesday, October 28, 2026)]
[Notices]
[Pages 67835-67836]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21909]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-12178]


Notice of Approval of Product Under Voucher: Material Threat 
Medical Countermeasure (MCM) Priority Review Voucher; Bixlenvo 
(Bictegravir and Lenacapavir)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
approval of a product redeeming a material threat MCM priority review 
voucher. The Federal Food, Drug, and

[[Page 67836]]

Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act 
(Cures Act), authorizes FDA to award priority review vouchers to 
sponsors of approved material threat MCM product applications that meet 
certain criteria. FDA is required to publish notice of the issuance of 
material threat MCM priority review vouchers as well as the approval of 
products redeeming a voucher. FDA has determined that Bixlenvo 
(bictegravir and lenacapavir), tablets, approved August 27, 2026, meet 
the redemption criteria.

FOR FURTHER INFORMATION CONTACT: Andrea Gormley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3751, email: 
<a href="/cdn-cgi/l/email-protection#7637181204131758201f181513180236101217581e1e0558111900"><span class="__cf_email__" data-cfemail="cf8ea1abbdaaaee199a6a1acaaa1bb8fa9abaee1a7a7bce1a8a0b9">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under section 565A of the FD&C Act (21 
U.S.C. 360bbb-4a), which was added by section 3086 of the Cures Act 
(Pub. L. 114-255), FDA will report the issuance of material threat MCM 
priority review vouchers and the approval of products for which a 
voucher was redeemed. FDA has determined that the application for, 
Bixlenvo (bictegravir and lenacapavir), tablets approved August 27, 
2026, meets the redemption criteria.
    For further information about the material threat MCM Priority 
Review Voucher Program and for a link to the full text of section 565A 
of the FD&C Act, go to <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions#prv">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions#prv</a>. For further information about 
Bixlenvo (bictegravir and lenacapavir), tablets go to the ``Drugs@FDA'' 
website at <a href="http://www.accessdata.fda.gov/scripts/cder/daf/">http://www.accessdata.fda.gov/scripts/cder/daf/</a>.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21909 Filed 10-27-26; 8:45 am]
BILLING CODE 4164-01-P


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