Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha)
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Issuing agencies
Abstract
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that OTARMENI (lunsotogene parvec-cwha), approved April 23, 2026, manufactured by Regeneron Pharmaceuticals, Inc., meets the criteria for a priority review voucher.
Full Text
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<title>Federal Register, Volume 91 Issue 87 (Wednesday, May 6, 2026)</title>
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[Federal Register Volume 91, Number 87 (Wednesday, May 6, 2026)]
[Notices]
[Pages 24549-24550]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08913]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-4588]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product; OTARMENI (lunsotogene parvec-cwha)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a rare
pediatric disease product application. The Federal Food, Drug, and
Cosmetic Act (FD&C Act) authorizes FDA to award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA is required to publish
notice of the award of the priority review voucher. FDA has determined
that OTARMENI (lunsotogene parvec-cwha), approved April 23, 2026,
manufactured by Regeneron Pharmaceuticals, Inc., meets the criteria for
a priority review voucher.
FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Biologics
Evaluation and Research, Food and Drug Administration,
<a href="/cdn-cgi/l/email-protection#2c454248595f585e55024e454340434b454f5f6c4a484d0244445f024b435a"><span class="__cf_email__" data-cfemail="4e27202a3b3d3a3c37602c2721222129272d3d0e282a2f6026263d60292138">[email protected]</span></a>, 240-402-7911.
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the
[[Page 24550]]
FD&C Act (21 U.S.C. 360ff), FDA will award priority review vouchers to
sponsors of approved rare pediatric disease product applications that
meet certain criteria. FDA has determined that OTARMENI (lunsotogene
parvec-cwha), manufactured by Regeneron Pharmaceuticals, Inc., meets
the criteria for a priority review voucher. OTARMENI (lunsotogene
parvec-cwha) is indicated for the treatment of pediatric and adult
patients with severe-to-profound and profound sensorineural hearing
loss (any frequency >90 dB HL) associated with molecularly confirmed
biallelic variants in the OTOF gene, preserved outer hair cell
function, and no prior cochlear implant in the same ear.
For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to <a href="https://www.fda.gov/industry/developing-products-rare-diseases-conditions/rare-pediatric-disease-rpd-designation-and-voucher-programs">https://www.fda.gov/industry/developing-products-rare-diseases-conditions/rare-pediatric-disease-rpd-designation-and-voucher-programs</a>. For further information about
OTARMENI (lunsotogene parvec-cwha), go to the Center for Biologics
Evaluation and Research's Approved Cellular and Gene Therapy Products
website at <a href="https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products">https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08913 Filed 5-5-26; 8:45 am]
BILLING CODE 4164-01-P
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