Palforzia Peanut Allergy Immunotherapy: Aimmune CEO on REMS, Manufacturing
Summary
Aimmune (NASDAQ: AIMT) president and CEO Jayson Dallas talked to our sister publication the Pink Sheet about the certification process, part of the company’s Risk Evaluation and Mitigation Strategy (REMS), in an interview in New York last month. He said clinics must go online and certify via a box check-off that they have the experience and staff to do immunotherapy and have access to the emergency allergic reaction treatment EpiPen (epinephrine injection) at all times. Palforzia was associated with a higher rate of systemic allergic reactions and epinephrine use in clinical trials, and to mitigate this risk the agency required Aimmune to implement a REMS. Once the patient is cleared to receive the product, the powder in the capsules, which consists of peanut flour, is emptied onto semisolid food, such as applesauce, yogurt or pudding. On 16 March, DBV announced that FDA had informed the company that during its ongoing review of the BLA it “identified questions regarding efficacy, including the impact of patch-site-adhesion.” Therefore, the Allergenic Products Advisory Committee that had been slated for 15 May will not take place as scheduled.
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