Takeda’s Entyvio snags second FDA approval as ‘subcutaneous option’ for Crohn’s disease
Click Here to Manage Email Alerts
The FDA has approved subcutaneous administration of Takeda Pharmaceuticals’ Entyvio for maintenance therapy in adult patients with moderate-to-severe Crohn’s disease following induction therapy via IV administration of the biologic.
Subcutaneous Entyvio (vedolizumab, Takeda Pharmaceuticals) was previously approved in 2023 for moderate-to-severe ulcerative colitis. The company noted that the drug is also currently available in the United States as the single-dose pre-filled Entyvio Pen.
The FDA based its decision on results from VISIBLE 2, 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 CD. Of the patients that achieved clinical response at week 6 after two doses of open-label IV vedolizumab at weeks 0 and 2, researchers randomly assigned 409 patients 2:1 at week 6 to receive either SC vedolizumab 108 mg or placebo by SC injection every 2 weeks.
According to study results, at week 52, a statistically significantly proportion of patients who received SC vedolizumab maintenance therapy achieved clinical remission —defined as total CDAI score of 150 — compared with those who received placebo (48% vs. 34%; P <0.01).
“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,” Timothy Ritter, MD, senior medical director at GI Alliance Research and assistant professor of medicine at TCU School of Medicine in Fort Worth, Texas, said in a press release. “In VISIBLE 2, about half of patients treated with Entyvio SC achieved long-term clinical remission. The data from VISIBLE 2 reaffirm the well-established efficacy profile of Entyvio, regardless of route of administration.”
The safety profile of SC vedolizumab was consistent with the previously established 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 approval of subcutaneous Entyvio in Crohn’s disease delivers on our goal of providing treatment options that can help patients achieve remission of their ulcerative colitis or Crohn’s disease, while also providing them flexibility and choice of route of administration,” Brandon Monk, senior vice president and head of the U.S. Gastroenterology Business Unit at Takeda, said in the release. “With Entyvio Pen, patients have the option of administering their maintenance treatment at home or on-the-go. Our development of a subcutaneous option demonstrates Takeda’s commitment to meeting the very real needs of those living with gastrointestinal diseases.”
Perspective
Back to Top
Shubha Bhat, PharmD, MS, FCCP, BCACP
Subcutaneous vedolizumab was first approved by the FDA in 2023 for patients with moderate to severe ulcerative colitis, and has been a welcomed addition for many patients seeking its efficacy and safety benefits from the comfort of their home or while on the go.
I am excited that this treatment option, via prefilled pen, is now also FDA-approved for moderate to severe Crohn’s disease. It provides these patients the opportunity to switch to subcutaneous vedolizumab 108 mg every 2 weeks after completing two IV induction doses at weeks 0 and 2 or switch to subcutaneous vedolizumab 108 mg every 2 weeks at the time of their next IV maintenance dose if they are established on treatment. They also can continue with IV maintenance dosing.
Despite vedolizumab pens being commercially available for several months, the payer landscape regarding insurance coverage and formulary positioning is still evolving. Regardless, practices will need to ensure they have adequate resources and support staff for dual prior authorization requests, given the general coverage of infusions under medical benefits and pens under pharmacy benefits.
Overall, the administration flexibility of vedolizumab addresses the previously existing barrier of patients not desiring infusion treatments for a variety of reasons, provides patients with more treatment choices and is a welcomed update for the IBD community.
Click Here to Manage Email Alerts