Aimmune’s Peanut Allergy Immunotherapy Brings Safety Concerns To US FDA Panel
Palforzia was associated with a higher rate of adverse events, systemic allergic reactions, eosinophilic esophagitis and epinephrine use in controlled clinical trials; Allergenic Products Advisory Committee will weigh approval for patients ages 4-17 years with confirmed peanut allergy diagnosis.
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The French company's hopes of joining Aimmune's Palforzia on the peanut allergy market soon have been shattered after US regulators issued a complete response letter to its Viaskin Peanut patch. A lot now depends on how much work DBV will have to do to satisfy the FDA.
Aimmune’s oral immunotherapy seems destined to come to market with a strict REMS, though analysts do not expect this will impact adoption. DBV is awaiting word on whether the FDA will review its second attempt at a BLA submission for Viaskin Peanut.
The agency’s plan to require a Risk Evaluation and Mitigation Strategy aimed at systemic allergic reactions with the peanut allergy immunotherapy did not go far enough, advisory committee members said, pushing for additional measures to be folded into the program.