Lack Of Ragwitek Efficacy Data In Older Patients No Hurdle To Panel Nod
Executive Summary
FDA advisory committee endorses the sublingual ragweed pollen allergy immunotherapy for patients ages 18-65 years even though Merck’s efficacy studies only went up to age 50. The sponsor conducted safety studies in older patients and presented other data to support an inference of efficacy in the over-50 population.
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