FDA approves subcutaneous Entyvio as maintenance treatment for ulcerative colitis

The FDA has approved Takeda Pharmaceutical’s Entyvio subcutaneous injection for the maintenance treatment of adult patients with moderate to severe ulcerative colitis after induction therapy with intravenous biologics.

An intravenous formulation of Entyvio (vedolizumab, Takeda Pharmaceuticals) was approved in 2014 for the treatment of moderate to severe UC and Crohn’s disease. Entyvio’s new formulation is expected to be available in a single-dose prefilled pen within the next month, the company noted.

“With the FDA’s approval of subcutaneous Entyvio, patients and physicians who want the clinical profile and dosing flexibility of Entyvio now have two options for the maintenance treatment of adults with moderate to severe ulcerative colitis,” Brandon Monk Takeda Senior Vice President and Head of U.S. Gastroenterology Business Unit said in a press release.

“Takeda is committed to meeting the diverse medical needs, circumstances and personal preferences of UC patients as they battle the disease throughout their lives,” Monk said. “Entyvio is the only FDA-approved biologic for the maintenance treatment of ulcerative colitis. formulations, offering the option of intravenous or subcutaneous administration.”

The FDA’s decision is based on results from VISIBILE 1, a Phase 3, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of subcutaneous (SC) vedolizumab as maintenance treatment in adults with moderate to severe UC . Among patients who achieved clinical remission at week 6 after receiving two doses of open-label IV vedolizumab at weeks 0 and 2, 162 patients were randomized in a 2:1 ratio to receive SC vedolizumab at week 6. Lizumab 108 mg or placebo injected subcutaneously every 2 weeks.

The primary endpoint of the study is clinical response at week 52, the release said.

At Week 52, a statistically significant proportion of patients receiving SC vedolizumab maintenance therapy achieved clinical remission compared with patients receiving placebo (46% vs. 14%, respectively; ask< .001).

The company reported that the safety profile of SC vedolizumab was consistent with that of intravenously administered vedolizumab, except for injection site reactions such as injection site erythema, rash, swelling, bruising, and hematoma when administered subcutaneously. The most common adverse events include nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and extremity pain.

“The VISIBLE 1 trial demonstrates that Entyvio SC may provide physicians with an additional dosing option to help patients with moderate to severe ulcerative colitis achieve remission,”Bruce Sands, M.D., Ph.D.,

Dr. Henry D. Janowitz, chief of the Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, said in a news release.

“Since its approval in 2014, Entyvio has continued to establish a strong safety and efficacy profile,” Sands added. “I am pleased to now have a subcutaneous delivery option that provides a clinical profile consistent with Entyvio IV while also allowing My fellow UC patients and I have choices about how we receive maintenance treatment.”

The company noted that the FDA is currently reviewing a biologics license application to study subcutaneous vedolizumab for the treatment of adults with moderate to severe Crohn’s disease.