An FDA advisory panel is scheduled to meet on September 13 to determine whether to recommend Aimmune Therapeutics' peanut allergy drug AR101 for approval, reported Bloomberg.
According to the news source, some analysts expect the panel to back AR101, but Stifel's Derek Archila suggested there may be a focus on the safety of the drug, which is derived from peanut flour.
"The crux of the [advisory committee meeting] will be if there is a need for longer-term safety data to really understand if you're putting these kids at undue risk by giving them the allergen they're allergic to," he said.
Aimmune CEO Jayson Dallas acknowledged that "there almost surely will be discussion around the macro-level risk/benefit, but then maybe digging into some patient populations."
A successful panel meeting followed by FDA approval over the coming months would make AR101 the first desensitization therapy approved for an allergy that affects more than 1.6 million children, the news source said.
The advisory panel may also impact DBV Technologies, which is developing a patch for peanut-allergic children ages four to 11. Last month, the company submitted its application for Viaskin Peanut after the FDA had previously requested additional data.
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