Entyvio: New Subcutaneous Option for Crohn’s Disease Patients

April 19, 2024

Takeda’s Entyvio, a medication for Crohn’s disease, has been approved for a subcutaneous (SC) formulation. Originally an intravenous (IV) infusion drug from 2014, this new option allows patients to self-administer the treatment with a prefilled pen, offering convenience and flexibility for at-home use. Takeda announced this label expansion after a similar approval for ulcerative colitis, providing patients the ability to choose between SC injections for more independence or IV therapy for continued healthcare provider interaction. Despite initial FDA concerns in 2019 about device design and labeling, which did not relate to safety or efficacy, these issues were resolved in a subsequent resubmission. Entyvio faces market competition from other subcutaneous drugs and oral treatments for Crohn’s, but its new SC option priced at $6,240 per two pens for 28 days may help reduce the day-to-day impact of the chronic condition.

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[Source: Endpoints, April 19th, 2024]

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