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Notice

Issuance of Priority Review Voucher; Rare Pediatric Disease Product

A Notice by the Food and Drug Administration on 12/17/2020

Document Details

Information about this document as published in the Federal Register.

Printed version:
PDF
Publication Date:
12/17/2020
Agencies:
Food and Drug Administration
Document Type:
Notice
Document Citation:
85 FR 81933
Page:
81933-81934 (2 pages)
Agency/Docket Number:
Docket No. FDA-2020-N-0026
Document Number:
2020-27778
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Docket Number:
FDA-2020-N-0026
Enhanced Content
Published Document

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease Start Printed Page 81934product 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 ZOKINVY (lonafarnib), manufactured by Eiger BioPharmaceuticals, Inc., meets the criteria for a priority review voucher.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Althea Cuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, Fax: 301-796-9856, email: althea.cuff@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

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 that ZOKINVY (lonafarnib), manufactured by Eiger BioPharmaceuticals, Inc., meets the criteria for a priority review voucher.

ZOKINVY (lonafarnib) is indicated in patients 12 months of age and older with a body surface area of 0.39 m2 and above:

  • To reduce the risk of mortality in Hutchinson-Gilford progeria syndrome
  • For the treatment of processing-deficient progeroid laminopathies with either:

○ Heterozygous LMNA mutation with progerin-like protein accumulation or

○ Homozygous or compound heterozygous ZMPSTE24 mutations

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 http://www.fda.gov/​ForIndustry/​DevelopingProductsforRareDiseasesConditions/​RarePediatricDiseasePriorityVoucherProgram/​default.htm. For further information about ZOKINVY (lonafarnib), go to the “Drugs@FDA” website at http://www.accessdata.fda.gov/​scripts/​cder/​daf/​.

Start Signature

Dated: December 14, 2020.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2020-27778 Filed 12-16-20; 8:45 am]

BILLING CODE 4164-01-P

Published Document