KCUR: FDA Committee Recommends Approval For New Peanut Allergy Treatment
A closely watched but controversial treatment for peanut allergies took a big step closer to becoming widely available.
On Friday, an advisory committee of the U.S. Food and Drug Administration voted 7-2 to approve Palforzia, a standardized peanut powder product, to help reduce allergic reactions to peanuts for patients ages 4 to 17 as part of oral immunotherapy protocol. The treatment was developed by pharmaceutical company Aimmune Therapeutics.
The committee's vote could be a landmark in addressing peanut allergies, which currently have no FDA-approved treatment, leaving allergic people little choice but to avoid peanuts. The FDA usually follows the recommendations of its advisory committees. A final decision is expected early next year.
The recommendation came despite concerns raised in some testimony that the treatment could actually lead to more allergic reactions, in some cases.
Peanut allergies have been increasing in recent years. It's now estimated that 2.2% children in the U.S. are allergic to peanuts. Oral immunotherapy doesn't cure these allergies but for some patients can make them more manageable. It is a regime of slowly increasing daily exposure to tiny amounts of peanut powder. Over the course of several months, it has been shown to reduce the incidence and severity of allergic reactions to small amounts of peanuts in many patients.
Palforzia provides a standardized, medical-grade version of the treatment, which some doctors already offer using peanut flour.
While studies showed that oral immunotherapy using Palforzia can reduce reactions, Aimmune researchers also said that the treatment carries side effects including nausea, itchiness in the throat and vomiting.
A public comment period included impassioned testimony by parents of children from across the country who had undergone and benefited from oral immunotherapy. Many of them disclosed that their travel costs had been paid by Aimmune.
These parents and patient advocates urged the committee to approve Palforzia, saying that it was unacceptable to have no treatment option.
However, other experts argue that's not the case because doctors can already provide the treatment with peanut flour obtained from a grocery store.
"Some patients would probably prefer to use an FDA-approved product," said Dr. Jay Portnoy, an allergist at Children Mercy, in Kansas City, Mo., and Allergenic Products Advisory Committee member who was involved in the Palforzia trials. He also provides oral immunotherapy using peanut flour.
"Other patients may decide to not worry about getting an FDA-approved product because the peanut flour [obtained from a grocery store] is very inexpensive. You don't have to get prior authorization. You don't have to have your health plan pay for it."
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