Imcivree

For acquired hypothalamic obesity (HO) 2 years and older with syndromic or monogenic…. NDA 213793, held by Rhythm. Setmelanotide Acetate.

As of Nov 14, 2026, NDA 213793 (Imcivree), held by Rhythm, was first approved by FDA on Nov 25, 2020, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 25, 2020
Review: Priority
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged: 4 years and older with acquired hypothalamic obesity (HO) 2 years and older with syndromic or monogenic obesity due to: o Bardet-Biedl syndrome (BBS) o Pro-opiomelanocortin (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).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below


Mar 19, 2026	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 20, 2024	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 16, 2022	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 25, 2020	Original applicationNew molecular entity · Priority review	Approved	Label Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
ImcivreeEQ 10MG BASE/ML (EQ 10MG BASE/ML) · solution;subcutaneous	Setmelanotide Acetate	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Mar 19, 2026	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 21, 2025	Supplement 8Labeling · Standard review	Approved	Label Letter
Dec 20, 2024	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 15, 2023	Supplement 5Labeling · Standard review	Approved	Letter Label
Jun 16, 2022	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 25, 2020	Original applicationNew molecular entity · Priority review	Approved	Label Review Letter

Identifiers

Application: NDA 213793
Drugs@FDA: Overview at FDA
Company: Rhythm Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters