FDA approves Takeda’s self-administered Entyvio for Crohn’s disease

The new formulation is taken as a maintenance therapy following induction with intravenous (IV) Entyvio.

Patients who have completed IV Entyvio will now have the option to self-administer the treatment via a single-dose, pre-filled pen.

The news comes after SC Entyvio was previously approved by the FDA in September 2023 for adults with ulcerative colitis (UC).

“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,” said Brandon Monk, senior vice president, head, U.S. Gastroenterology Business Unit at Takeda.

“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.”

Crohn’s disease is a complex and often progressive disease. Both Entyvio IV and SC are important administration options to help patients who live with moderate to severe Crohn’s disease, Takeda said.

The approval is based on the visible 2 study, a phase 3 trial which assessed the safety and efficacy of a subcutaneous (SC) formulation of Entyvio.

According to Takeda, a statistically significant proportion of patients receiving Entyvio maintenance therapy administered every 2 weeks achieved long-term clinical remission, compared to patients receiving placebo.

Common adverse reactions included nasopharyngitis, headache, arthralgia and nausea.

“Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve remission,” said Timothy Ritter, senior medical director at GI Alliance Research and assistant professor of medicine, TCU School of Medicine.

“In Visible 2, about half of patients treated with Entyvio SC achieved long-term clinical remission. The data from VISIBLE 2 reaffirm the well-established efficacy profile of ENTYVIO, regardless of route of administration.”