FDA approves Takeda’s ENTYVIO SC for Crohn’s disease

2024-04-19

临床结果临床3期上市批准

来源: Pharmaceutical Technology

The safety profile of Takeda’s TENTYVIO SC in the trial was aligned with the IV formulation. Credit: Michael Vi via Shutterstock.

The US Food and Drug Administration (FDA) has granted approval for Takeda’s ENTYVIO subcutaneous (SC) administration as a maintenance therapy to treat adults with moderately to severely active Crohn’s disease (CD).

ENTYVIO SC is intended for usage as maintenance treatment in moderately to severely active CD patients following induction therapy using intravenous (IV) ENTYVIO.

In September 2023, the FDA approved the SC administration of ENTYVIO as a maintenance treatment in adults with moderately to severely active ulcerative colitis patients and is available as a single-dose prefilled pen (ENTYVIO Pen) in the US.

The latest approval is based on the findings from the double-blind, randomised, placebo-controlled Phase III VISIBLE 2 Study analysing the safety and efficacy of ENTYVIO SC.

Trial data showed that a significant 48% of patients receiving ENTYVIO SC every two weeks achieved long-term clinical remission, compared to 34% of those on placebo.

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ENTYVIO SC’s safety profile in the trial was in line with the IV formulation, with injection site reactions noted as an adverse reaction.

Takeda US gastroenterology senior vice-president and head Brandon Monk said: “The approval of subcutaneous ENTYVIO in Crohn’s disease delivers on our goal of providing treatment options that can help patients achieve remission of their ulcerative colitis or Crohn’s disease, while also providing them flexibility and choice of route of administration.

“With ENTYVIO Pen, patients have the option of administering their maintenance treatment at home or on the go.

“Our development of a subcutaneous option demonstrates Takeda’s commitment to meeting the very real needs of those living with gastrointestinal diseases.”

Last month, the Japanese Ministry of Health, Labour and Welfare approved the company’s ADZYNMA Intravenous Injection 1500 to treat congenital thrombotic thrombocytopenic purpura.

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