FDA approves subcutaneous Entyvio as maintenance therapy for ulcerative colitis
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The FDA has approved subcutaneous administration of Takeda Pharmaceuticals’ Entyvio for maintenance therapy in adult patients with moderate-to-severe ulcerative colitis following induction therapy via IV administration of the biologic.
The IV formulation of Entyvio (vedolizumab, Takeda Pharmaceuticals) was approved in 2014 for both moderate-to-severe UC and Crohn’s disease. The company noted that the new formulation of Entyvio is expected to be available as single-dose pre-filled pen within the next month.
“With the FDA approval of subcutaneous Entyvio, patients and physicians who want Entyvio’s clinical profile along with flexibility of administration now have two choices for maintenance treatment for adults with moderate to severe ulcerative colitis,” Brandon Monk, senior vice president and head of the U.S. Gastroenterology Business Unit at Takeda, said in a press release.
“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,” Monk said. “Entyvio is the only FDA-approved biologic for maintenance therapy in ulcerative colitis offering the option of either intravenous or subcutaneous administration.”
The FDA based its decision on results from VISIBILE 1, a phase 3, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of subcutaneous (SC) vedolizumab as maintenance therapy in adults with moderate-to-severe UC. Of the patients that achieved clinical response at week 6 after two doses of open-label IV vedolizumab at weeks 0 and 2, 162 were randomly assigned 2:1 at week 6 to receive either SC vedolizumab 108 mg or placebo by SC injection every 2 weeks.
The study’s primary endpoint was clinical remission at week 52, the release stated.
At week 52, a statistically significantly proportion of patients who received SC vedolizumab maintenance therapy achieved clinical remission compared with those who received placebo (46% vs. 14%; P< .001).
The safety profile of SC vedolizumab was consistent with IV vedolizumab’s safety profile, other than injection site reactions such as injection site erythema, rash, swelling, bruising and hematoma with SC administration, the company reported. The most common adverse events reported were nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.
“The VISIBLE 1 trial demonstrated that Entyvio SC can provide physicians with an additional administration option for achieving remission in their moderate to severe ulcerative colitis patients, “Bruce Sands, MD, MD, chief of the Dr. Henry D. Janowitz division of gastroenterology at the Icahn School of Medicine at Mount Sinai, said in the release.
“Since its approval in 2014, Entyvio has continued to build a robust safety and efficacy profile,” Sands added. “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.”
The company noted that a biologics license application is also currently under review by the FDA for an investigational subcutaneous administration of vedolizumab for the treatment of adults with moderate-severe Crohn’s disease.
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