Entyvio(vedolizumab)
Immunology· 696 cited findings· 1 source document
What the regulatory reviews say
Entyvio (vedolizumab) was approved in 2021. Clinical remission at Week 52 demonstrated efficacy, with a 32-point treatment difference versus placebo. For patients with prior TNF blocker failure, the treatment difference in clinical remission at Week 52 versus placebo was 25. For those without prior TNF blocker failure, this difference was 34. Improvement of endoscopic appearance of the mucosa at Week 52 showed a 36-point treatment difference versus placebo.
Notable safety findings include an overall incidence of hypersensitivity reactions at 20% and injection site reactions for Entyvio SC at 9%. Adverse events leading to discontinuation occurred in 8.9% of subjects. The recommended dosage for Entyvio SC maintenance regimen is 108 mg every two weeks. A deferral of pediatric studies for Entyvio SC was requested.
Key figures — cited to the source page
| Clinical remission at Week 52 (treatment difference vs placebo) | 32 | Takeda Pharmaceutical Company Limited — Entyvio FDA Review, p.48 |
| Clinical remission at Week 52 (prior TNF blocker failure, treatment difference vs placebo) | 25 | Takeda Pharmaceutical Company Limited — Entyvio FDA Review, p.48 |
| Clinical remission at Week 52 (without prior TNF blocker failure, treatment difference vs placebo) | 34 | Takeda Pharmaceutical Company Limited — Entyvio FDA Review, p.48 |
| Improvement of endoscopic appearance of the mucosa at Week 52 (treatment difference vs placebo) | 36 | Takeda Pharmaceutical Company Limited — Entyvio FDA Review, p.48 |
| Overall incidence of hypersensitivity reactions | 20 | Takeda Pharmaceutical Company Limited — Entyvio FDA Review, p.34 |
| Injection site reactions for Entyvio SC | 9 | Takeda Pharmaceutical Company Limited — Entyvio FDA Review, p.85 |
| AEs leading to discontinuation | 8.9 | Takeda Pharmaceutical Company Limited — Entyvio FDA Review, p.159 |
| Year of Approval | 2021 | Takeda Pharmaceutical Company Limited — Entyvio FDA Review, p.18 |
Source documents
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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.