[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Notices]
[Pages 81929-81930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27760]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0026]


Issuance of Priority Review Voucher; Rare Pediatric Disease 
Product

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 IMCIVREE (setmelanotide) injection, manufactured by Rhythm 
Pharmaceuticals, Inc., meets the criteria for a priority review 
voucher.

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: [email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority 
review voucher to the sponsor of an

[[Page 81930]]

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 
IMCIVREE (setmelanotide) injection, manufactured by Rhythm 
Pharmaceuticals, Inc., meets the criteria for a priority review 
voucher. IMCIVREE (setmelanotide) injection is indicated for the 
treatment of chronic weight management in adult and pediatric patients 
6 years of age and older with proopiomelanocortin (POMC), proprotein 
convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) 
deficiency obesity confirmed by genetic testing demonstrating variants 
in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, 
likely pathogenic, or of uncertain significance.
    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 IMCIVREE (setmelanotide) injection, go to the 
``Drugs@FDA'' website at http://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27760 Filed 12-16-20; 8:45 am]
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