FDA Approves Vedolizumab to Treat Ulcerative Colitis & Crohn’s Disease

4 years ago
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us food and drug administration

 

The U.S. Food and Drug Administration (FDA) approved new drug Entyvio (vedolizumab) for the treatment of moderate to severe ulcerative colitis and Crohn’s disease. Vedolizumab is given injectable form. FDA has approved its use in patients with ulcerative colitis or Crohn’s disease in whom one or more o standard therapies like corticosteroids, immunomodulators or tumor necrosis factor (TNF) blocker medication have not shown an adequate response.

Safety and effectiveness of Vedolizumab for ulcerative colitis were established in two clinical trials which include patients who had not responded to standard therapies as mentioned above. Results showed that patients treated with Vedolizumab compared to placebo achieved and maintained clinical response, clinical remission, achieved corticosteroid-free clinical remission and had improved the appearance of the colon seen on endoscopy.

Same for Crohn’s disease were established in three trials, results of which showed that a greater percentage of patients treated with Vedolizumab compared to a placebo achieved a clinical response, achieved clinical remission and achieved corticosteroid-free clinical remission.

Vedolizumab is an integrin receptor antagonist. Integrins receptors are proteins expressed on the surface of certain cells which function as bridges for cell-cell interaction. Vedolizumab blocks interaction of specific integrin receptor which is expressed on circulating inflammatory cells with a specific protein which is expressed on cells in the interior wall of blood vessels and thereby blocks migration of those circulating inflammatory cells across those blood vessels and into areas of inflammation in the gastrointestinal tract.

Side effects of Vedolizumab include a headache, joint pain, nausea, fever, the risk of serious infections, hypersensitivity, infusion related reaction, and hepatotoxicity. Another type of integrin receptor antagonist is associated with progressive multifocal leukoencephalopathy (PML), which is a rare but often fatal opportunistic infection of CNS which is caused by a virus and occurs in immunocompromised patients (patients with low immunity). In clinical trials of Vedolizumab, PML was not seen in patients but doctors prescribing it are advised to monitor patients for neurological side effects which could help find cases of PML.

Ulcerative colitis and Crohn’s disease are inflammatory bowel disease which is due to inflammation of gastrointestinal tract. Symptoms of ulcerative colitis include diarrhea (most common), rectal bleeding, the passage of mucus in stools and crampy abdominal pain. Symptoms of Crohn’s disease includes abdominal pain, diarrhea, fever, loss of appetite and many more complications related symptoms.

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