The US Food and Drug Administration (FDA) has approved Aimmune Therapeutics’ Palforzia to treat peanut allergy in children aged four to 17 years.
Said to be the first drug approved for this indication, Palforzia is oral immunotherapy indicated to mitigate allergic reactions that could arise due to accidental exposure to peanuts.
The drug, manufactured in powdered form from peanuts, can be taken in initial dose escalation, up-dosing and maintenance phases.
A single day of initial dose escalation will be followed by the up-dosing phase, which comprises 11 increasing dose levels over several months. The daily maintenance dose begins after the completion of the up-dosing phase.
Up-dosing and maintenance of treatment may be continued in people aged four years and above. The FDA recommends that people taking the drug must avoid peanuts in their diets.
FDA Center for Biologics Evaluation and Research director Peter Marks said: “Peanut allergy affects approximately one million children in the US and only one out of five of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions.
“When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy.”
FDA approval comes from safety and efficacy results from seven clinical studies, including the pivotal Phase III PALISADE and RAMSES trials, Phase II ARC001 trial and the open-label ARC002 follow-on study.
Aimmune also included results from the ongoing ARC004, ARC008 and ARC011 trials.
The company has started working with allergists to prepare for the safe integration of the drug into their practices.