The regulator has authorised Entyvio as a maintenance drug for individuals with moderately to highly active Crohn's disease after intravenous Entyvio-based induction therapy
FDA clears Takeda’s Entyvio SC for Crohn’s disease. (Credit: Takeda Pharmaceutical Company Limited)
Takeda has received the US Food and Drug Administration (FDA) approval for the subcutaneous (SC) administration of Entyvio (vedolizumab) to treat certain type of Crohn’s disease patients.
The FDA has authorised Entyvio as a maintenance drug for individuals with moderately to highly active Crohn’s disease after intravenous (IV) Entyvio-based induction therapy.
Takeda’s biologics license application (BLA) for this indication was accepted by the FDA in September last year.
Entyvio SC administration was also approved by the FDA in September 2023 for the maintenance treatment of individuals with moderately to highly active ulcerative colitis (UC). The drug is currently available in the US as a single-dose prefilled pen, dubbed Entyvio Pen.
The approval was supported by data from the VISIBLE 2 Study (SC CD trial) that evaluated the safety and effectiveness of an Entyvio SC formulation.
The Phase 3 randomised, double-blind, placebo-controlled trial randomised 409 patients at Week 6 in a 2:1 ratio to Entyvio 108mg administered by SC injection or placebo every second week. This was after the patients were given two doses of open-label vedolizumab intravenous therapy at Weeks 0 and 2.
VISIBLE 2 had clinical remission at Week 52 as the primary endpoint, which was defined as a total Crohn’s Disease Activity Index (CDAI) score of ≤150.
As per the results, a statistically significant percentage of patients receiving Entyvio SC 108mg maintenance therapy provided every two weeks achieved long-term clinical remission at Week 52 compared to those receiving a placebo.
The safety profile of Entyvio SC in clinical studies was found to be mostly in line with the established safety profile of the IV version.
Takeda gastroenterology business unit US head and senior vice president Brandon Monk said: “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.
“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.”
Vedolizumab SC is also approved for use in the EU and over 50 other countries.