3850S1_04_FDA-CHOWDHURY 9.14.37 PM

3850S1_04_FDA-CHOWDHURY 9.14.37 PM - Clinical Development...

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Clinical Development Programs for Chronic Idiopathic Urticaria Indication for H1-antihistamines Badrul A. Chowdhury, MD, PhD Medical Team Leader, Division of Pulmonary and Allergy Drug Products, CDER, US FDA
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2 Outline General overview on urticaria and clinical program for chronic idiopathic urticaria (CIU) CIU clinical programs Summary remarks
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3 Types of Urticaria Acute Urticaria Lasts for less than 6 weeks Can occur with anaphylaxis Chronic urticaria – Daily or almost daily urticaria for at least 6 weeks – Very unusual to find a cause : CIU Intermittent urticaria Bouts of urticaria lasting days or weeks with intervals of days, weeks, or months Urticaria of known cause – Physical urticaria; delayed pressure urticaria; cold urticaria; cholinergic urticaria
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4 Clinical Features of CIU Repeated occurrence of short-lived cutaneous wheals or hives Can occur anywhere on the skin Few mm to several cm in diameter Wheals are paler than the surrounding red skin Individual wheals lasts less than 24 hours Itching at and around the wheals Redness or erythema of the skin
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5 Clinical Program for CIU Indication The FDA requires evidence of efficacy from at least two clinical studies, including exploration of the appropriate dose, and demonstration of safety of the proposed dose Pivotal efficacy studies are randomized, multi-center, double-blind, parallel group, placebo-controlled, and are often active-controlled Safety of the proposed dose must be demonstrated Wheal-and-flare suppression studies are not considered as substantial evidence of efficacy
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6 Patients Enrolled in CIU Studies Males and females 12 or 18 years and older and free of clinically significant diseases Clinical diagnosis of CIU Excluded: patients with physical urticaria; cholinergic urticaria; urticaria due to known cause; urticaria associated with underlying diseases; hereditary angioedema or C1 esterase deficiency Important differentials: urticarial vasculitis; erythema multiforme; urticaria pigmentosa (cutaneous or systemic mastocytosis); non-specific maculopapular exanthems; cutaneous blistering disease, e.g., bullous pemphigoid, dermatitis herpetiformis
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7 Patients Enrolled in CIU Studies Active urticaria on study entry Symptomatic for 3 or 6 consecutive weeks with hives present for 50% of the days or 2 days/week or 3 days/week Enriched patient population
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This note was uploaded on 01/02/2012 for the course STEP 1 taught by Professor Dr.aslam during the Fall '11 term at Montgomery College.

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3850S1_04_FDA-CHOWDHURY 9.14.37 PM - Clinical Development...

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