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FDA Accepts Application for Subcutaneous Entyvio for UC
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The FDA has accepted a biologic license application for a subcutaneous formulation of Entyvio for maintenance therapy in adults with moderately-to-severely active ulcerative colitis, according to a company press release.
“Acceptance of this regulatory submission for review brings us one step closer to our goal of better meeting the diverse needs of patients with ulcerative colitis in the U.S.,” Uthra Sundaram, senior vice president of the GI business unit at Takeda Pharmaceuticals U.S.A., said in the release. “The availability of a subcutaneous option for maintenance therapy with [Entyvio (vedolizumab)], in addition to the currently approved intravenous formulation, would provide physicians and patients with greater flexibility on route of administration, if approved.”
The proposal — which would make Entyvio available in pre-filled syringes and pens — is based on the positive results from the phase 3 VISIBLE 1 trial that was presented at UEG Week 2018.
The study showed that more patients who received subcutaneous vedolizumab were able to achieve clinical remission at week 52 of treatment compared with patients who received placebo (46.2% vs. 14.3%; P < .001). It also achieves similar rates of clinical remission compared with intravenous vedolizumab.
“The VISIBLE 1 study provides us with important knowledge on the characterization of the efficacy and safety profile for the investigational subcutaneous formulation of vedolizumab,” Karen Lasch, MD, medical head of specialty GI in the U.S. Medical Office at Takeda said in the release. “Takeda is deeply committed to bringing innovative medicines and treatment modalities to patients living with gastrointestinal diseases.”
The European Marketing Agency recently accepted a marketing authorization line extension application for a subcutaneous formulation of Entyvio for maintenance therapy in adults with moderately-to-severely active UC and Crohn’s disease.
Disclosures: Lasch and Sundaram are employed by Takeda.
Perspective
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Adam Cheifetz, MD
Having subcutaneous vedolizumab for the maintenance of remission of ulcerative colitis is an exciting proposition. The VISIBLE 1 trial showed us that the subcutaneous formulation is at least as effective as the intravenous formulation at maintaining remission and more effective than placebo.
An additional method of delivery would give physicians a lot more flexibility and be more convenient for some patients. A lot of patients would prefer to self-administer an injection every 2 weeks, as opposed to coming into an infusion center every 8 weeks. They would be able to do it at home and prevent having to take off from work or other activities.
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