The allergenic products advisory committee will review the biologics license application for AR101, a drug designed as a treatment to reduce the frequency and severity of adverse events, including anaphylaxis, following exposure to peanuts.
Aimmune said it will be ready to launch AR101 by Q4. The FDA previously informed Aimmune that completion of its review would be targeted by late Jan. 2020. The FDA granted the drug fast track designation and breakthrough therapy designation for peanut-allergic children and adolescents ages 4 to 17.
The company also said it has entered into a commercial supply agreement with privately-held CoreRx, the manufacturer of AR101.
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