Takeda wins FDA approval for subcutaneous Entyvio in ulcerative colitis

The FDA has approved a subcutaneous version of Takeda’s ulcerative colitis drug Entyvio, more than three years after rejecting the company’s application over what it said were issues related to the design and labeling of the device.

The drug will be available as a single-dose pre-filled pen by the end of October. It’s approved for use after induction therapy with intravenous Entyvio (vedolizumab), Takeda announced Wednesday.

Entyvio was first approved in 2014 to treat ulcerative colitis and Crohn’s disease through a roughly 30-minute-long infusion. The latest approval gives ulcerative colitis patients the choice between intravenous maintenance therapy or a self-administered injection. A separate application for a subcutaneous formulation to treat Crohn’s patients is currently being reviewed by the FDA. A decision on that is expected in 2024, according to a Takeda spokesperson.

The company said it will reveal the price of the pre-filled pen in the coming days.

Regulators rejected Takeda’s first attempt at a subcutaneous approval for Entyvio in December 2019, though the company has emphasized that the agency’s concerns were “unrelated to the clinical safety and efficacy data” from a pivotal trial and also unrelated to the intravenous formulation. Takeda included additional data with its resubmission in May, at which point the subcutaneous formulation had already been approved in Europe, Canada and Australia.

Brandon Monk

“Takeda is committed to meeting the varied medical needs, circumstances and personal preferences of people living with UC as they progress in their lifelong journey with the disease,” Brandon Monk, senior VP and head of Takeda’s US gastroenterology business unit, said in a news release.

Takeda’s gastroenterology products generated more than $7.3 billion (1.09 trillion yen) in its fiscal year 2022, driven by Entyvio sales, the company reported in May.

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