The U.S. Food and Drug Administration approved vedolizumab (Entyvio) injections to treat adult patients diagnosed with moderate-to-severe ulcerative colitis and Crohn disease after inadequate response to one or more standard therapies.
Over 1 million Americans have been diagnosed with ulcerative colitis or Crohn disease. Vedolizumab is approved to treat these diseases when standard treatment with corticosteroids, immunomodulators, or tumor necrosis factor blocker medications have failed.
“Although there is no cure for these conditions, [this] approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy to help control their symptoms.” Amy G. Egan, MD, MPH, said in a press release from the FDA.
In two trials involving approximately 900 ulcerative colitis patients, a larger percentage of patients assigned to vedolizumab achieved and maintained clinical response and remission compared with patients assigned to placebo. Patients in the vedolizumab group also had improved colon appearance on endoscopy.
In three trials involving 1,500 patients diagnosed with Chron disease, a larger percentage of patients assigned to vedolizumab achieved greater response and remission rates compared with patients given a placebo.
The most common side effects associated with vedolizumab include headache, joint pain, nausea, and fever. The most serious adverse events include serious infections, hypersensitivity and infusion-related reactions, and hepatotoxicity.
The FDA advises health care professionals to monitor patients treated with vedolizumab for any new onset or worsening of neurological signs and symptoms.