Imcivree
Metabolic· 1621 cited findings· 3 source documents
Company: Rhythm B V
What the regulatory reviews say
Imcivree is a drug indicated for obesity and hyperphagia in patients with genetic conditions such as pro-opiomelanocortin (POMC) deficiency and leptin receptor (LEPR) deficiency. Clinical trials demonstrated an average percent decrease from baseline in body weight of 23.1% and 9.7%. In the LEPR deficiency obesity population, 45.5% of patients achieved a weight loss of more than 10%. The drug also showed an increase in resting energy expenditure of 111 kcal/24h or 6.4% compared to placebo.
Common safety findings included injection site reactions (96%), hyperpigmentation of the skin and hair (78%), nausea (56%), and diarrhea (37%). Psychiatric adverse events were also noted, with 46.4% of patients experiencing at least one psychiatric disorder-related AE, including depression (30%) and insomnia (15%). Spontaneous penile erection was reported in 23% of patients.
Imcivree received orphan medicinal product designation for POMC deficiency on 14 July 2016 and for leptin receptor deficiency on 19 November 2018. The marketing authorization application was submitted on 26 June 2020. The drug was granted PRIME eligibility on 28 June 2018.
Key figures — cited to the source page
| Average percent decrease from baseline in body weight (POMC) | 23.1 | RHYTHM — Imcivree FDA Review (NDA213793, ORIG 1, 2020), p.14 |
| Average percent decrease from baseline in body weight (LEPR) | 9.7 | RHYTHM — Imcivree FDA Review (NDA213793, ORIG 1, 2020), p.15 |
| Resting energy expenditure increase vs placebo | 111 | RHYTHM — Imcivree FDA Review (NDA213793, ORIG 1, 2020), p.27 |
| Injection site reactions | 96 | RHYTHM — Imcivree FDA Review (NDA213793, ORIG 1, 2020), p.11 |
| Hyperpigmentation of the skin and hair | 78 | RHYTHM — Imcivree FDA Review (NDA213793, ORIG 1, 2020), p.11 |
| At least one psychiatric disorder related AE | 46.4 | RHYTHM — Imcivree FDA Review (NDA213793, ORIG 1, 2020), p.11 |
| Orphan medicinal product designation date for POMC deficiency | 14 July 2016 | Rhythm B V — Imcivree EMA EPAR public assessment report (EME, p.8 |
| Marketing authorization application submission date | 26 June 2020 | Rhythm B V — Imcivree EMA EPAR public assessment report (EME, p.8 |
Source documents
Explore the full evidence
All 1621 cited findings for Imcivree — searchable, comparable and answerable in plain language — are in the Metabolic research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.