Rhythm B V — Imcivree EMA EPAR public assessment report (EMEA/H/C/005089, 2021)
Rhythm B V · 2021 · EMA EPAR public assessment report · company profile →
Report summary
Rhythm Pharmaceuticals' Imcivree (setmelanotide) received EMA marketing authorization for obesity and hunger associated with POMC and LEPR deficiencies, rare genetic conditions causing severe early-onset obesity. Granted PRIME designation due to unmet medical need, Imcivree is an MC4R agonist. Manufacturing, quality control, and non-clinical studies confirmed its efficacy in reducing body weight and improving metabolic parameters, with a favorable safety profile. Clinical trials demonstrated significant weight loss and hunger reduction, particularly in POMC patients. Common adverse events included skin hyperpigmentation and gastrointestinal issues, with rare but noted concerns like depression and suicidal ideation. The overall benefit-risk balance was deemed positive given the high unmet medical need.
Key findings — cited to the page
| Mean Cmax,ss (3 mg QD, preserved mPEG-DSPE formulation) | 37.9 ng/mL | RM-493-026 · p.52 |
| Median Tmax (SC injection, preserved mPEG-DSPE formulation) | 8.0 h | · p.52 |
| Mean AUCtau (3 mg QD, preserved mPEG-DSPE formulation) | 495 h*ng/mL | RM-493-026 · p.52 |
| CHMP positive opinion date for marketing authorisation | 20 May 2021 | Imcivree · p.11 |
| Procedure start date | 16 July 2020 | · p.10 |
| Accelerated Assessment procedure agreement date | 30 April 2020 | · p.10 |
| Marketing authorization application submission date | 26 June 2020 | Imcivree · EU · p.8 |
| Worldwide known incidence of bi-allelic POMC/PCSK1/LEPR deficiency obesities | less than 200 patients | Global · p.103 |
| Orphan medicinal product designation date for leptin receptor deficiency | 19 November 2018 | Imcivree · EU · p.8 |
| PRIME eligibility grant date | 28 June 2018 | Imcivree · p.8 |
| Orphan medicinal product designation date for POMC deficiency | 14 July 2016 | Imcivree · EU · p.8 |
| LS Mean percent change in hunger score from baseline | -57.32 | RM-493-015 (Supplemental) · p.98 |
Source: Rhythm B V ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →