About 1.2 million American children have peanut allergies. A new drug, Palforzia, does not cure the condition, but it can blunt life-threatening reactions.
A Food and Drug Administration panel on Friday recommended approval of the first-ever drug to treat life-threatening peanut allergies in children, a condition that confounds and frightens families across the country.
The recommendation all but assures the agency will approve the drug, called Palforzia and made by Aimmune Therapeutics. The F.D.A. typically follows the advice of its expert advisory committees.
Some panel members expressed reservations about the safety of the drug, since patients receiving treatment experienced more allergic reactions than those given a placebo. There is also little long-term safety data about a treatment that may be lifelong, the critics noted.
The drug’s goal is not to cure the allergy, but to reduce the risk that an accidental exposure to small amounts of peanut will set off a life-threatening reaction. It might also relieve some of the fear and anxiety many families experience as they struggle to cope with a child’s severe peanut allergy…
But several experts at the hearing raised questions about the drug’s long-term safety and effectiveness.
Nina Zeldes, a senior fellow at the National Center for Health Research in Washington, pointed out that only one study had examined the drug’s effectiveness. The participants were mostly white, she also noted, so little is known about how children of other backgrounds may respond to treatment. Long-term consequences of exposure to the drug are unknown.
“This is the first treatment for peanut allergies, and if this drug is approved despite the unanswered questions, it will set a precedent for future drugs to treat food allergies,” Ms. Zeldes said.
The group urged the F.D.A. to require additional research data about risks before approving the drug, “because it will be difficult if not impossible to obtain it afterward,” Ms. Zeldes said…
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