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WASHINGTON (AP) – Government experts on Friday supported an experimental treatment for peanut allergic children that could become the first option approved by the federal government for the prevention of life-threatening reactions.
The treatment consists of daily capsules of peanut powder that gradually help children develop tolerance.
The group of external advisors of the Food and Drug Administration voted overwhelmingly in favor of the treatment of Aimmune Therapeutics. The non-binding vote is equivalent to an approval for approval.
The FDA should make its final decision in January.
Panelists said the drug was an important option for parents and children with peanut allergy. However, many have also expressed concerns because the pill must be taken continuously to maintain its effect.
In the United States, approximately 1.6 million children and adolescents are eligible for the drug sold as Palforzia for children aged 4 to 17 years.
Peanut allergy is the most common food allergy in the country and the standard treatment is to strictly monitor what children eat. This approach does not always work and accidental exposure is common, sending every year 1 child allergic to peanuts out of 4 in the emergency room.
At the Friday meeting, parents urged approval for the drug, describing the concern of monitoring the diet and the daily lives of their children and even avoiding public places and means of transport because of peanut residues .
"These are constant and real fears with extreme consequences," said Cathy Heald of Dallas, whose son, Charlie, aged 12, participated in a study on treatment.
Heald said the increased tolerance of his son had allowed him to travel abroad on his own for the first time.
"The tranquility of mind brought by this treatment is invaluable," said Hill, whose trip to the meeting was paid by Aimmune.
After one year, about 66% of study participants who took the tablets could tolerate the equivalent of three to four peanuts, compared to only 4% of patients who received dummy treatment. At the beginning of the study, most participants did not even tolerate a minute amount of peanuts.
But the benefits of treatment involved risks. More than 9% of patients taking the pills reported serious allergic reactions, more than twice as much as in the placebo group. And 11% of patients dropped out of the company's study because of side effects.
"The effectiveness of the treatment has actually not been demonstrated," said Dr. John Kelso, of the San Diego Scripps Clinic, who voted against the treatment.
The California company has previously said it expects the first six months of treatment to cost between $ 5,000 and $ 10,000 and between $ 300 and $ 400 a month. The company declined to specify the price earlier this week.
Aimmune is pursuing other treatments for common food allergies, including eggs. The company does not have any products on the market yet.
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Follow Matthew Perrone on Twitter: @AP_FDAwriter
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