An analyst called the patch "dead in the water," also noting that the ongoing Covid-19 pandemic could challenge the rollout of a competing therapy, Aimmune's Palforzia, which the FDA approved in January.
The company said Friday that the agency had accepted for review its application for Viaskin Peanut, designed to reduce the risk of allergic reactions in children aged 4-11. An FDA advisory committee voted in favor of a competing treatment last month.
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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.