FDA Approves Pen Form of Entyvio for Crohn’s Disease

The FDA has approved Takeda’s Entyvio (vedolizumab) subcutaneous for maintenance therapy in adults with moderate-to-severe active Crohn’s disease. It is administered every two weeks after induction therapy with the intravenous formulation. The subcutaneous formulation was also approved in September 2023 for the maintenance treatment of adults with moderate-to-severe active ulcerative colitis.

Entyvio is available as a single-dose prefilled pen with a wholesale acquisition cost of $6,239.94 for two pens. Entyvio is also available as an intravenous solution for $8,666.58 for one vial.

“Ensuring patients have access to the medicines they need is a top priority for Takeda. This is a process that requires discussion with private and government payers/providers, which ultimately determine what medications are available to their members,” a Takeda spokesperson said. “Takeda will work diligently so that commercially and government-insured patients have access to Entyvio SC.”

Takeda says more than 90% of patients are commercially insured without step edits. The company offers a copay program for commercial patients for $5 a dose, with a maximum benefit of $20,000 a year.

In the terms of the copay program, Takeda notes that the program “is intended solely for the benefit of you—not health plans and/or their partners… Takeda will monitor program utilization data and reserves the right to discontinue assistance under the Co-Pay Program at any time if Takeda determines that you are subject to a co-pay maximizer, accumulator, or similar program.”

Takeda notes that for patients with copay or maximizer programs, the maximum benefit will be lowered to $9,000 a year.

The approval of the pen formulation for Crohn’s is based on VISIBLE 2, a phase 3 trial enrolled 409 patients and assessed the safety and efficacy of this formulation in active disease. The primary endpoint was clinical remission at week 52, which was defined as a total Crohn’s Disease Activity Index, a scale used to measure disease activity.

A statistically significant proportion of patients (48%) receiving the subcutaneous Entyvio maintenance therapy achieved long-term clinical remission compared with patients receiving placebo (34%) at week 52. In clinical studies, the Entyvio SC safety profile was generally consistent with Entyvio IV. Additional adverse events with the subcutaneous form include with injection site reactions such as erythema, rash, pruritus, swelling, bruising, hematoma, pain, urticaria and edema.

“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. In VISIBLE 2, about half of patients treated with Entyvio SC achieved long-term clinical remission,” Timothy Ritter, M.D., senior medical director, Department of Research and Education, GI Alliance Research and assistant professor of medicine, TCU School of Medicine, said in a news release.