Imcivree (setmelanotide)
- Region
- 🇪🇺 EU
- Active substance
- setmelanotide
- Company
- Rhythm Pharmaceuticals Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Obesity
- CHMP opinion
- Thu 20 May 2021
- EU approval
- Fri 16 Jul 2021
- Designations
- Orphan, PRIME
- Application
- EMEA/H/C/005089
- ATC
- A08AA
- Official record
- www.ema.europa.eu
Indication
Imcivree is indicated for the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (aHO) due to hypothalamic injury or impairment. Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet Biedl syndrome (BBS) in adults and children 2 years of age and above. Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above.
Regulatory milestones
IMCIVREE: PDUFA target action date (acquired hypothalamic obesity)
Rhythm Pharmaceuticals, Inc. (RYTM); setmelanotide; sNDA; status: set; "…ata from Phase 3 TRANSCEND trial of Setmelanotide in Patients with Acquired Hypothalamic Obesity -- - 18.8% placebo-adjusted difference in BMI reduction achieved in all patients (N=142) at 52 weeks, including 12 Japanese patients and 10 supplemental patients with acquired hypothalamic obesity -- -- March 20, 2026…"; filed 2026-03-02 · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.