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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: setmelanotide
Trade Name: Imcivree
Date Designated: 11/27/2017
Orphan Designation: Treatment of leptin receptor deficiency
Orphan Designation Status: Designated/Approved
Rhythm Pharmaceuticals, Inc.
222 Berkeley St. Suite 1200
Boston, Massachusetts 02116
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: setmelanotide
Trade Name: Imcivree
Marketing Approval Date: 11/25/2020
Approved Labeled Indication: Chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
Exclusivity End Date: 11/25/2027 
Exclusivity Protected Indication* :  Chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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