Urticaria – Unmet Need – Detailed, Expanded Analysis: Chronic Urticaria (US/EU)

Treatment of chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) is dominated by oral medications—both approved (e.g., first- and second-generation antihistamines) and used off-label (e.g., DMARDs, immunosuppressants, tricyclic antidepressants). However, several of these drug classes can have serious side effects, and many patients still struggle to control their symptoms. Novartis / Roche’s Xolair is the first and only FDA-approved biologic for CSU, although other biologics are used off-label. Clinical trials of additional biological and oral targeted therapies are under way, but with only one biologic approved for chronic urticaria, the factors that can positively differentiate emerging drugs from current therapies remain unknown, and many unmet needs in this space remain unfulfilled.

Questions answered

  • Following the approval of Xolair, what unmet needs remain in the treatment of chronic urticaria?
  • Which clinical trial endpoints and nonclinical attributes are key influencers of dermatologists’ and allergists’ prescribing decisions, and which have limited impact? What are areas of hidden opportunity?
  • How does Xolair perform on key treatment drivers and goals? How does its performance compare with that of frequently prescribed conventional therapies, including immunosuppressants and antihistamines?
  • What trade-offs across different clinical attributes and price are acceptable to U.S. and European dermatologists and allergists for a hypothetical new chronic urticaria drug?

Product description

Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. One market scenario is profiled in detail by Clarivate experts, and additional customized market scenarios can be evaluated with the corresponding TPP Simulator.

Key feature

The Target Product Profile (TPP) Simulator tool allows for customizable market simulations based on conjoint analysis that depicts how physicians make decisions based on actual behavior rather than opinion. Compare up to seven TPPs across multiple disease-specific attributes and price points to gauge which variables influence prescribing behavior.

Geography: United States, France, Germany, United Kingdom

Primary research: Survey of 60 U.S. and 30 European dermatologists and allergists

Key drugs covered: Xolair, Dupixent, antihistamines, montelukast, immunosuppressants

Content highlights: The TPP Simulator based on conjoint analysis methodology, stated versus derived importance of product attributes on prescribing behavior, assessment of current drug performance against treatment drivers and goals, physician perceptions of unmet needs in the indication and related indications, analysis of remaining drug development opportunities.

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