Crohn’s Disease | Unmet Need | US/EU | 2016

Although TNF-α inhibitors revolutionized the treatment landscape for moderate to severe Crohn’s disease (CD), considerable unmet need remains. For instance, a notable percentage of patients do not respond or lose response to TNF-α inhibitors over time, and there are few alternative treatments available. The launch of Entyvio (vedolizumab), a cell adhesion molecule (CAM) inhibitor, provides a possible treatment option for these patients, but additional agents are needed. Fistula formation is a common complication associated with moderate to severe CD that can significantly impact a patient’s QOL, and treatment options are also limited for this subpopulation. Moreover, biologics, the most effective therapies for moderate to severe CD, are IV or SC delivered; therefore, novel oral therapies with comparable or superior efficacy to biologics also present an attractive commercial opportunity. Indeed, the level of unmet need for moderate to severe CD remains high, and significant opportunity persists for therapies able to differentiate from competitors by addressing important areas of unmet need, such as improved efficacy on maintenance of clinical remission, treating fistulizing disease, effectively addressing the population of patients who do not respond/lose response to TNF-α inhibitors, and/or providing a more-convenient delivery formulation (i.e., oral).





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