The recent FDA and European Commission approvals of Takeda Pharmaceuticals’ drug Entyvio for the treatment of ulcerative colitis and Crohn’s disease has given doctors and patients a promising new therapeutic option to tackle these diseases.
As described by the largest pharmaceutical company in Japan, “ulcerative colitis (UC) and Crohn’s disease (CD) are marked by inflammation in the lining of the gastrointestinal tract.” While UC impacts the large intestine only, CD can impact any part of the digestive tract. There is currently no known cause nor definitive cure for UC and CD, which affect more than 4 million people worldwide.
With few solutions available to treat these diseases, Entyvio offers a promising alternative to treat adults with moderately to severely active UC and CD when other medicines for these diseases have not worked well enough or cannot be tolerated. According to information available in Entyvio’s website, the drug helps with the symptons, as well as it may help induce remission of UC and CD. In addition, people who respond to Entyvio may be able to reduce or stop the use of corticosteroid medicines.
There is, however, the potential for side effects that may be caused by the drug, suchs as allergic reactions, infections, progressive multifocal leukoencephalopathy (a rare, serious brain infection caused by a virus), and liver problems. The clinical trial program that was conducted as part of the FDA approval process showed that 52% of the patients in the study using the drug reported adverse reactions. In addition, only 37% of the patients in the study who were given placebo reported any adverse reactions.
Even so, doctors are enthusiastic about the new treatment. Stephen B. Hanauer, medical director of the Digestive Health Center, at Northwestern University Feinberg School of Medicine, considers that the clinical trial program “evaluated the efficacy and safety profile of Entyvio” and demonstrated that it “has the potential to help adult patients with moderately to severely active UC or CD successfully manage their disease.” Paul Rutgeerts, Emeritus Professor of Medicine at Catholic University of Leuven, Belgium, sees the approval of vedolizumab in Europe as “an important step forward in the treatment of ulcerative colitis and Crohn’s disease,” adding that the provides doctors with “a new therapeutic option to help us to tackle these challenging diseases.”
Besides the United States, Entyvio is now approved for marketing in the 28 member states of the European Union, as well as Norway, Iceland and Liechtenstein.
Patients who want to know more about the drug can find answers at EntyvioConnect.