U.S. FDA Approves Subcutaneous Administration Of Takeda's ENTYVIO For Maintenance Therapy In Moderately To Severely Active Ulcerative Colitis
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Takeda Pharmaceuticals (TAK) has received approval from the U.S. Food and Drug Administration (FDA) for a subcutaneous administration of ENTYVIO for maintenance therapy in adults with moderately to severely active ulcerative colitis. The new administration method is expected to be available in the U.S. by the end of October. Takeda does not expect this approval to materially impact its full year consolidated reported forecast for the year ending March 31, 2024.

September 27, 2023 | 8:27 pm
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Takeda's ENTYVIO has received FDA approval for a new administration method, potentially expanding its market reach. However, Takeda does not expect this to have a material impact on its FY2023 forecast.
The FDA approval of a new administration method for ENTYVIO potentially expands its market reach and usage, which could positively impact Takeda's revenues in the long term. However, the company does not expect this to have a material impact on its FY2023 forecast, suggesting that the financial impact in the short term may be limited.
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IMPORTANCE 70
RELEVANCE 100