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Imcivree FDA Approval History

FDA Approved: Yes (First approved November 25, 2020)
Brand name: Imcivree
Generic name: setmelanotide
Dosage form: Injection
Company: Rhythm Pharmaceuticals, Inc.
Treatment for: Obesity

Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist for chronic weight management of obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency.

Development Timeline for Imcivree

DateArticle
Nov 27, 2020ApprovalFDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency
Jul  1, 2020Rhythm Pharmaceuticals Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Setmelanotide for Treatment of POMC and LEPR Deficiency Obesities
May 13, 2020Rhythm Pharmaceuticals Announces FDA Acceptance of New Drug Application for Setmelanotide for the Treatment of POMC and LEPR Deficiency Obesities
Mar 30, 2020Rhythm Pharmaceuticals Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Setmelanotide in POMC and LEPR Deficiency Obesities
Mar 18, 2020Rhythm Pharmaceuticals Receives Orphan Drug Designation from U.S. FDA for Setmelanotide for the Treatment of Alström Syndrome
Dec 13, 2018Rhythm Pharmaceuticals Announces First Patient Enrolled in Pivotal Phase 3 Clinical Trial Evaluating Setmelanotide in Bardet-Biedl and Alström Syndromes
Jun 14, 2018Rhythm Pharmaceuticals Completes Pivotal Enrollment in Two Ongoing Phase 3 Clinical Trials Evaluating Setmelanotide in Rare Genetic Disorders of Obesity

Further information

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