OSAKA, Japan & CAMBRIDGE, Mass. - Takeda Pharmaceutical Company (NYSE:TAK) Limited (TSE:4502/NYSE:TAK) has received approval from the U.S. Food and Drug Administration (FDA) for the subcutaneous administration of ENTYVIO (vedolizumab) as a maintenance therapy for adults with moderately to severely active Crohn's disease. This follows an earlier approval for the same formulation for ulcerative colitis patients in September 2023.
The FDA's decision is supported by the results of the VISIBLE 2 Study, a Phase 3 clinical trial that demonstrated the efficacy and safety of ENTYVIO in maintaining clinical remission in Crohn's disease patients. Approximately half of the participants in the trial achieved long-term remission at Week 52, a significant improvement over the placebo group. The safety profile for the subcutaneous administration was consistent with the known profile of the intravenous form, with injection site reactions as an additional adverse reaction.
ENTYVIO, a biologic therapy, works by targeting the alpha4beta7 integrin, which plays a role in the inflammation process associated with Crohn's disease and ulcerative colitis. With over one million patient years of exposure globally, vedolizumab is available in both intravenous and subcutaneous forms across numerous markets.
Dr. Timothy Ritter, a senior medical director at GI Alliance Research, highlighted the importance of treatment options that can achieve remission in these chronic conditions. Takeda's senior vice president, Brandon Monk, emphasized the company's commitment to providing flexible treatment options that address the needs of those living with gastrointestinal diseases.
ENTYVIO's subcutaneous form is now available in the U.S. as a single-dose prefilled pen, offering patients the convenience of at-home or on-the-go administration. Takeda does not anticipate a material impact on its consolidated financial statements following this approval.
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