TAKEDA , Vedolizumab Gains Priority Review Status for Ulcerative Colitis (UC) – An Endorsement of its Differentiated Clinical Profile for Treating UC!

Date: 2015-07

Takeda received priority review status from US FDA for its late stage candidate Vedolizumab (filed for UC and Crhon’s disease (CD), a4ß7 integrin inhibitor) to treat ulcerative colitis indication. Vedolizumab targets the disease by preventing leukocyte extravasations through inhibiting a4ß7 integrin in the gut which is different from currently used second line options, mainly anti-TNFs (Remicade, Humira, Simponi). The key limitations with these drugs are their low response rate (~40% do not respond) and lost of response over time (~30%-40%). We understand that dose escalation and switch to a second anti-TNF recapture the response in 40-80% of patients but after 12 months the response rate drops significantly. This creates a huge unmet need for a drug which …………..On pipeline front…………..The report discuss in details unmet need, late stage pipeline drugs and competitive landscape of ulcerative colitis and crohn’s disease treatment options.

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