The new treatment will be used for patients with ulcerative colitis and Crohn's disease who have not responded to other forms of treatment.
A new treatment has been approved by the FDA for the treatment of Crohn’s disease and ulcerative colitis. Monoclonal antibody vidolizumbab, whose brand name is Entyvio, will be used to treat adults who suffer from moderate-to-severe forms of either disease, especially those who did not respond to other forms of treatment.
It works by binding to intigrin receptors in cells which helps mitigate anti-inflammatory responses in the immune system. By suppressing these responses, inflammatory cells are unable to travel to areas that are already inflamed.
The treatment was tested in two clinical trials featuring 900 participants diagnosed with ulcerative colitis. People who received the treatment were able to show significant responses to the treatment that included sustained remission without dependency on corticosteroid treatments.
Similar results were garnered from clinical trials involving 1,500 patients diagnosed with Crohn’s disease. Additional tested has demonstrated slightly more pronounced results in ulcerative colitis, though.
In a press release on May 20, Dr. Amy Egan, from the FDA Office of Drug Evaluation said, “Ulcerative colitis and Crohn’s disease are debilitating diseases that impact the quality of life of those who have these conditions.” She points out that since there is no cure for either ailment, this latest treatment provides hope and relief for individuals who have not responded to conventional forms of treatment for their symptoms.
One of the dangers involved in treatments that suppress the immune system stems from the ability of a JC virus common in everyone to reactivate, causing an infection known as progressive multifocal leukoencephalopathy. This infection attacks myelin production, causing neurological symptoms that can be life-threatening. Other drugs that suppress integrin receptors have been known to be associated with this complication, but in clinical trials none of the patients treated with vidolizumbab developed this complication.
The FDA plans to continue monitoring reactions to the treatment and update its findings should instances of this infection start to appear.
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