Palforzia, previously called AR101, was developed by Aimmune Therapeutics to reduce the severity of an allergic reaction to peanuts in case of accidental exposure.
After members of the peanut allergy community urged the panelists to vote in favor of advancing the drug to the final approval stage, the FDA panel voted 7-2 to endorse Palforzia.
The vote is not binding, but the FDA tends to follow the recommendations of the advisory panels, according to STAT.
The panel also voted 8-1 to approve three safety requirements pending Palforzia’s approval. First, the FDA should require documentation that any patient using Palforzia has a valid prescription for epinephrine, the lifesaving allergy treatment. Second, that patients or their caregivers agree to carry injectable epinephrine at all times while they take Palforzia. Third, that the initial dose escalation and first dose of each up-dosing level be administered in a certified facility capable of treating systemic allergic reactions.
The FDA still needs to complete a full review of Palforzia before it becomes available to patients.
Read the full article here.
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