Document ID: FDA-2014-N-0229-0004
Agency: fda
Document Type: Notice
Title: Use of Rare Pediatric Disease Priority Review Voucher; Approval of a Drug
Product
Posted Date: 2015-08-24T04:00Z

[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Page 51277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20833]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0229]

Use of Rare Pediatric Disease Priority Review Voucher; Approval 
of a Drug Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
recent approval of a drug product under an application for which the 
sponsor redeemed a rare pediatric disease priority review voucher. The 
Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 
Food and Drug Administration Safety and Innovation Act (FDASIA), 
authorizes FDA to redeem priority review vouchers submitted by sponsors 
of product applications that might otherwise not qualify for priority 
review. These vouchers entitle the holder of such a voucher to priority 
review of a single human drug application submitted under the FD&C Act 
or the Public Health Service Act. FDA has approved PRALUENT 
(alirocumab), manufactured by Sanofi-Aventis U.S. Inc., under a 
priority review.

FOR FURTHER INFORMATION CONTACT: Larry Bauer, Rare Diseases Program, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4842, 
FAX: 301-796-9858, email: larry.bauer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is announcing the recent approval of a 
drug product under an application for which the sponsor redeemed a rare 
pediatric disease priority review voucher. Under section 529 of the 
FD&C Act (21 U.S.C. 360ff), added by FDASIA, FDA will grant a priority 
review for a new drug or biological product application that redeems a 
priority review voucher, even if that product might not otherwise 
qualify for a priority review. FDA has recently approved PRALUENT 
(alirocumab), manufactured by Sanofi-Aventis U.S. Inc., under a 
priority review. PRALUENT (alirocumab) is indicated as an adjunct to 
diet and maximally tolerated statin therapy for the treatment of adults 
with heterozygous familial hypercholesterolemia or clinical 
atherosclerotic cardiovascular disease, who require additional lowering 
of low-density lipoprotein cholesterol.
    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 PRALUENT (alirocumab), go to the 
Drugs@FDA Web site at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.

    Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20833 Filed 8-21-15; 8:45 am]
BILLING CODE 4164-01-P