The FDA’s Allergenic Products Advisory Committee voted 7-2 in favor of supporting the efficacy profile of Palforzia, or AR101. Some committee members expressed concerns about a lack of diversity in the Phase III clinical trial.
Although the study of AR101 met its primary endpoint, patients on the drug had more allergic reactions than those on placebo. An allergy expert explained that the disparity reflects time needed to build up tolerance to peanut allergen.
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The report found that Aimmune's AR101 and DBV's Viaskin Peanut lacked sufficient evidence to demonstrate that their benefits outweighed short-term risks. Aimmune and an allergy advocacy group criticized the report.