Issuance of Priority Review Voucher; Rare Pediatric Disease Product; MODESYO (dordaviprone)
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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 MODESYO (dordaviprone), approved August 6, 2025, manufactured by Chimerix, Inc., meets the criteria for a priority review voucher.
Full Text
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<title>Federal Register, Volume 90 Issue 165 (Thursday, August 28, 2025)</title>
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[Federal Register Volume 90, Number 165 (Thursday, August 28, 2025)]
[Notices]
[Pages 42018-42019]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16515]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-3082]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product; MODESYO (dordaviprone)
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 MODESYO (dordaviprone), approved August 6, 2025, manufactured by
Chimerix, Inc.,
[[Page 42019]]
meets the criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT: Quyen Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 301-796-2771.
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 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 MODESYO (dordaviprone) manufactured by Chimerix,
Inc., meets the criteria for a priority review voucher. MODESYO
(dordaviprone) capsules are indicated for the treatment of adult and
pediatric patients 1 year of age and older with diffuse midline glioma
harboring an H3 K27M mutation with progressive disease following prior
therapy.
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/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm">https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm</a>. For further
information about MODESYO (dordaviprone), go to the ``Drugs@FDA''
website at <a href="https://www.accessdata.fda.gov/scripts/cder/daf/">https://www.accessdata.fda.gov/scripts/cder/daf/</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16515 Filed 8-27-25; 8:45 am]
BILLING CODE 4164-01-P
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