Takeda Pharmaceutical Company Limited — Entyvio FDA Review (BLA761133, ORIG 1, 2023)
Takeda Pharmaceutical Company Limited · 2023 · FDA Review (openFDA) · company profile →
Report summary
The FDA review recommends approval for Takeda's Entyvio (vedolizumab) subcutaneous injection and pen for maintenance treatment of moderately to severely active ulcerative colitis in adults. The resubmission successfully addressed prior deficiencies related to the device and formulation. Efficacy, demonstrated in Study SC-3027, showed significant clinical remission at Week 52. The safety profile is consistent with the intravenous formulation, with injection site reactions being the primary difference. Immunogenicity, malignancies, infections, and liver enzyme abnormalities were assessed, with no new safety concerns identified. The review confirms established safety and effectiveness, resolving previous manufacturing and human factors issues.
Key findings — cited to the page
| Grade 3 CPK elevations | 4 % | Study SC-3027 · p.61 |
| Grade 3 CPK elevations | 0 % | Study SC-3027 · p.61 |
| Grade 3 CPK elevations | 1 % | Study SC-3027 · p.61 |
| Grade 4 CPK increases | 2 % | Study SC-3030 · p.61 |
| Grade 4 CPK elevations | 2 % | Study SC-3027 · p.61 |
| Grade 3 CPK increases | 3 % | Study SC-3030 · p.61 |
| Injection site irritation events (clinical trials SC-3027/SC-3030) | 1 | Studies SC-3027/SC-3030 · p.74 |
| Injection site irritation events (postmarketing) | 6 | · p.74 |
| Deferral of pediatric studies for Entyvio SC | requested | Entyvio (vedolizumab) injection and Entyvio Pen (vedolizumab) injection, for subcutaneous use · p.83 |
| PREA Postmarketing Requirement (PMR) 4493-2 study completion date | 06/2028 | PMR 4493-2 · p.87 |
| Countries with SC approval | 44 countries | Entyvio (vedolizumab) · Global · p.22 |
| PREA Postmarketing Requirement (PMR) 4493-2 final report submission date | 12/2028 | PMR 4493-2 · p.87 |
Source: Takeda Pharmaceutical Company Limited ↗ · 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 Immunology library →