FDA OKs Subcutaneous Vedolizumab (Entyvio) for UC Maintenance Therapy 

Megan Brooks

September 28, 2023

The US Food and Drug Administration (FDA) has approved the subcutaneous (SC) administration of vedolizumab (Entyvio SC, Takeda) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) following induction therapy with intravenous administration of vedolizumab.

The company expects vedolizumab SC to be available in the United States as a single-dose pre-filled pen (Entyvio Pen) by the end of October.

The FDA approved the IV formulation of the biologic in 2014 for patients with moderate to severe UC and Crohn's disease who have failed or cannot tolerate other therapies. 

The approval of vedolizumab SC was based on the results of the phase 3, randomized, double-blind, placebo-controlled VISIBLE 1 trial.  

The trial assessed the safety and efficacy of maintenance therapy with SC vedolizumab in adult patients with moderately to severely active UC who achieved clinical response at week 6 following two doses of vedolizumab IV.

At week 6, a total of 162 patients were randomly allocated (2:1) to vedolizumab or placebo by subcutaneous injection every 2 weeks. The primary endpoint was clinical remission at week 52, defined as a total Mayo score of 2 or less and no individual subscore greater than 1.

At week 52, nearly half (46%) of patients who received vedolizumab SC maintenance therapy achieved clinical remission compared with 14% of those who received placebo SC (P < .001).

The safety profile of vedolizumab SC was "generally consistent" with that of vedolizumab IV, with the addition of injection site reactions, Takeda said in a news release.

The most common adverse reactions with vedolizumab IV are nasopharyngitis, headache, arthralgia, nausea, pyrexia (fever), upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in the extremities.

Vedolizumab SC "can provide physicians with an additional administration option for achieving remission in their moderate to severe ulcerative colitis patients," Bruce Sands, MD, chief of gastroenterology at the Icahn School of Medicine at Mount Sinai in New York City, said in the news release.

"I appreciate now having a subcutaneous administration option that provides a clinical profile consistent with Entyvio IV while also giving me and my appropriate UC patients a choice of how they receive their maintenance therapy," Sands added.

The FDA is currently reviewing Takeda's biologics license application for SC administration of vedolizumab in the treatment of adults with moderately to severely active Crohn's disease.

Sands is a paid consultant of Takeda Pharmaceuticals U.S.A., Inc. He has not been compensated for media work.

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