Mysimba
Metabolic· 922 cited findings· 2 source documents
Company: Orexigen
What the regulatory reviews say
Mysimba is a combination drug indicated for weight management in adults. It is approved for use in patients with a Body Mass Index (BMI) of ≥30 kg/m2, or ≥27 kg/m2 in the presence of at least one weight-related comorbidity. The Marketing Authorisation Application was submitted on 2 October 2013, and a CHMP positive opinion was issued on 18 December 2014.
In clinical trials, Mysimba demonstrated efficacy in reducing total body weight. One study showed an LS mean percent change in total body weight of -4.8% compared to placebo, with a p-value of < 0.001. The mean baseline weight of subjects in this study was 99.8 kg, with a mean baseline BMI of 36.2 kg/m2. The study population had a mean age of 44 years, with 85.1% female subjects.
Regarding safety, the incidence of Major Adverse Cardiovascular Events (MACE) in the ITT population was 1.3% and 0.8%, with a Hazard Ratio of 0.59. In the PP population, MACE incidence was 0.6% and 0.5%, with a Hazard Ratio of 0.79. Treatment-emergent Serious Adverse Events (SAEs) were observed in 2.5% of the NB32 group and 1.6% of the NB16 group.
Key figures — cited to the source page
| LS Mean difference from placebo (NB32) | -4.81 | Orexigen — Mysimba EMA EPAR public assessment report (EMEA/H, p.53 |
| p-value for NB16 vs placebo | < 0.001 | Orexigen — Mysimba EMA EPAR public assessment report (EMEA/H, p.53 |
| MACE incidence (ITT population) | 1.3 | Orexigen — Mysimba EMA EPAR public assessment report (EMEA/H, p.99 |
| MACE Hazard Ratio (ITT population) | 0.59 | Orexigen — Mysimba EMA EPAR public assessment report (EMEA/H, p.99 |
| Indication BMI threshold | ≥30 | Orexigen — Mysimba EMA EPAR public assessment report (EMEA/H, p.7 |
| Indication BMI threshold with risk factors | ≥27 | Orexigen — Mysimba EMA EPAR public assessment report (EMEA/H, p.7 |
| CHMP positive opinion date | 18 December 2014 | Orexigen — Mysimba EMA EPAR public assessment report (EMEA/H, p.9 |
| US Marketing Authorisation date | 10 September 2014 | Orexigen — Mysimba EMA EPAR public assessment report (EMEA/H, p.8 |
Source documents
Explore the full evidence
All 922 cited findings for Mysimba — 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.