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Taking Takeda's Entyvio TreatmentCrohn's DiseasePatients now have the option of subcutaneous injection.

Takeda announced the good news on Friday. A few months ago, the subcutaneous formulation was approved for the first time in China.Ulcerative ColitisEntyvio or vedolizumab was initially approved in 2014 as an intravenous infusion drug, administered over approximately 30 minutes.

New Formulation for Maintenance Treatment After Intravenous Entyvio Induction. This is a single-dose, pre-filled pen that can be self-administered "at home or on the go," said Brandon Monk, Head of Takeda’s U.S. Gastroenterology Business Unit, in a press release.

"Some patients may prefer SC administration because it allows for flexible self-administration in a home setting, while others may prefer IV administration due to more regular contact points with healthcare providers," a Takeda spokesperson said. By meeting patients' needs and preferences, we hope to reduce the impact of chronic conditions on patients' daily lives.

Priced at approximately $6,240 every 28 days, or for two pens.

In December 2019, Takeda's first attempt at subcutaneous approval for Entyvio failed due to concerns about the device's "design and labeling." The company stated at the time that the FDA's issues were not related to clinical safety or efficacy data. These concerns were clarified in a resubmission last year, by which time the formulation had already been approved in Europe, Canada, and Australia.

The Crohn's disease market is crowded with competitors, including Johnson & Johnson's Stelara and AbbVie's Humira and Skyrizi, all of which can be administered as subcutaneous injections. AbbVie’s Rinvoq was approved last year as a once-daily pill for treating Crohn’s disease patients who have failed at least one TNF blocker.

Source: https://endpts.com/

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