RHYTHM — Imcivree FDA Review (NDA213793, ORIG 1, 2020)
RHYTHM · 2020 · FDA Review (openFDA) · company profile →
Report summary
The FDA review recommends approval of IMCIVREE (setmelanotide) for chronic weight management in adults and children aged 6+ with obesity due to POMC, PCSK1, or LEPR deficiency. This orphan drug, granted Breakthrough Therapy Designation, demonstrated substantial effectiveness in pivotal trials (RM-493-012, RM-493-015), showing significant weight loss and improved metabolic parameters. Common adverse events included injection site reactions and hyperpigmentation, with rare but serious concerns like suicidal ideation. The benefits are deemed to outweigh the risks for these rare genetic conditions, for which no other effective treatments exist. Labeling updates address dosing, discontinuation criteria, and safety warnings.
Key findings — cited to the page
| IND opened | 112595 | RM-493 · U.S. · p.19 |
| Application Number | 213793 | · p.2 |
| Orphan Drug Designation | 27 Nov 2017 | setmelanotide · p.22 |
| Breakthrough Therapy Designation (BTD) | 01 May 2017 | setmelanotide · p.22 |
| Orphan Drug Designation | 04 Apr 2016 | setmelanotide · p.22 |
| Study RM-493-012 Duration of Treatment | 52 weeks | RM-493-012 · p.29 |
| Study RM-493-015 N | 13 | RM-493-015 · p.29 |
| Study RM-493-015 Duration of Treatment | 52 weeks | RM-493-015 · p.29 |
| Resting energy expenditure increase vs placebo | 111 kcal/24h | · p.27 |
| Resting energy expenditure increase vs placebo | 6.4 % | · p.27 |
| Study RM-493-012 N | 14 | RM-493-012 · p.29 |
| Weight increase after 4 weeks on placebo (Patient 3) | 147.0 to 150.5 kg | · p.105 |
Source: RHYTHM ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →