American biopharmaceutical company Gilead Sciences (Nasdaq: GILD) and Belgian Galapagos NV (Euronext & Nasdaq: GLPG) have announced positive top-line results from the SELECTION phase 2b/3 clinical trial, which evaluated the safety and efficacy of the selective JAK1 inhibitor filgotinib for the treatment of adults with moderate-to-severe ulcerative colitis … The SELECTION Phase 2b/3 trial is a multi-center, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of the selective JAK1 inhibitor filgotinib in adult patients with moderately to severely active ulcerative colitis. “The SELECTION study assessed the efficacy and safety of filgotinib in some of the most difficult-to-treat patients with ulcerative colitis, including a high proportion of patients who were refractory to biologic treatment and in need of new treatment options,” said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos. Ulcerative colitis is a long term, chronic condition which affects more than 2 million people in the European Union alone. Is it one of the most effective? “ The SELECTION study assessed the efficacy and safety of filgotinib in some of the most difficult-to-treat patients with ulcerative colitis, including a … Symptoms of ulcerative colitis can include […] The SELECTION trial comprises 2 Induction Trials and a Maintenance Trial. Ulcerative colitis is a type of inflammatory bowel disease that affects about 1 million people in the U.S. To help write our consultation response, which will set out our views, we want to hear from people with Ulcerative Colitis who have been treated with filgotinib.. We want to know what effect the medicine had on your symptoms and how you live your life, as well as how filgotinib compares to other medicines you have taken for your Ulcerative Colitis. Is filgotinib one of the safest Jak inhibitors for ulcerative colitis? “The SELECTION study assessed the efficacy and safety of filgotinib in some of the most difficult-to-treat patients with ulcerative colitis, including a … SELECTION (NCT02914522) is investigating two doses of filgotinib (100 mg and 200 mg filgotinib once daily), compared to placebo, as an induction and … Not so much, an opinion confirmed by the 6% share price slide in … Probably, according to the results from the Selection trial released late yesterday. “ We are pleased to see that SELECTION results indicate that filgotinib can help ulcerative colitis patients, including those refractory to … Efficacy and safety of filgotinib as induction therapy for patients with moderately to severely active ulcerative colitis: results from the phase 2b/3 SELECTION study. It is an autoimmune disease that affects the digestive system, causing inflammation in the innermost lining of the large intestine (colon). In terms of competition, experts support the potential of greater JAK1 selectivity with filgotinib and upadacitinib compared to Pfizer’s Xeljanz (tofacitinib)—the only approved JAK inhibitor for ulcerative colitis— but await clinical data to confirm an advantage. Galapagos NV recently announced that it has dosed the first patient with ulcerative colitis (UC) in its SELECTION Phase 2b/3 clinical trial, investigating the efficacy and safety of two doses of filgotinib as a UC treatment.. United European Gastroenterology Week , Amsterdam Oct 10–13, 2020 (abstr LB19). Filgotinib may soon become an option for ulcerative colitis patients. There is also the possibility of unfavorable results from ongoing and additional clinical trials involving filgotinib, including the SELECTION long-term extension trial and the DIVERSITY trial.
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