Entyvio for Crohn's disease: How it works and why it is different
The US Food and Drug Administration (FDA) has approved the drug Takeda's Entyvio™ (vedolizumab) for treating Crohn's disease that could help people living with ulcerative colitis and Crohn's disease manage symptoms when conventional drug approaches have failed.
Entyvio blocks inflammation
The drug that is manufactured by Takeda pharmaceuticals in Japan is a biological therapy that essentially stops inflammatory proteins from reaching the GI tract.
Crohn's disease can affect any part of the gastrointestinal tract including the mouth because it is an autoimmune disease.
In a press release Amy G. Egan, M.D., M.P.H., acting deputy director of the Office of Drug Evaluation III in the FDA‘s Center for Drug Evaluation and Research called approval of Entyvio an "....important new treatment option for patients who have had an inadequate response to conventional therapy to help control their symptoms.” There is no known cure for the disease.
The medication is known as an integrin receptor antagonist. What that means is that the drug uses a protein to block inflammatory cell receptors. The result is that the protein selectively prohibits the inflammatory cells from reaching the blood vessels and gastrointestinal tract. Integrins are found on the surface of cells.
Entyvio was studied in three clinical trials that included 1500 patients. Compared to placebo, remission rates were higher in the group given vedolizumab.The medication also improved appearance of the colon.
Another option for treatment
The medication is now approved for patients with active Crohn's or ulcerative colitis whose response to corticosteroids is diminished, no longer respond to TNF blockers.
"Patients with moderately to severely active ulcerative colitis or Crohn's disease, and the healthcare professionals who care for them, need additional new treatment options," said Douglas Cole, president, Takeda Pharmaceuticals U.S.A., Inc.
What patients should know
The most common side effects in clinical trials included headache, nausea, fever, joint pain, rash and respiratory symptoms including nasal inflammation and discharge.
A small number of patients experienced serious reactions (7 percent with vedolizumab vs 4 percent given placebo).
Entyvio is given intravenously over 30 minutes and requires observation during infusion. Anaphylaxis - a life-threatening allergic reaction - has been reported with the medication.
No one receiving Entyvio developed progressive multifocal leukoencephalopathy (PML) in clinical trials that has been associated with another type of integrin receptor agonist, atalizumab The rare neurological disease is cause by a virus. People with compromised immunity are more susceptible than the general population.
Before receiving the drug patients should be up to date with recommended vaccines. According to the FDA ulcerative colitis (UC) affects approximately 620,000 Americans and more than half a million people have been diagnosed with Crohn's disease.
The FDA approval of Entyvio (vedolizumab) for treating Crohn's disease and ulcerative colitis offers those suffering from the inflammatory bowel diseases another option that could mean extended periods of remission without steroids.
Updated October 4, 2014