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A new drug could become the first ever protective treatment for more than one million American children with peanut allergies.
In a phase three trial, the results of which were published in the New England Journal of Medicine, The drug AR101, derived from peanuts, has helped some children with severe peanut allergies to tolerate the equivalent of two peanut kernels without serious side effects. Before taking the drug, none of these children could safely ingest more than one-tenth of the kernel.
The AR101, manufactured by Aimmune Therapeutics (the company also designed and funded the study), provides a controlled daily dose of peanut protein, with the goal of creating tolerance over time and minimizing risks of accidental exposure to peanut. Enhancing tolerance is a well-established strategy to prevent new peanut allergies and reduce existing ones, but there is currently no drug to support them.
The AR101 still needs approval from the Food and Drug Administration (FDA). But the results of the new trial are encouraging, especially as peanut allergies are growing and affecting about 2.5% of American children, according to recent estimates.
TIME Health Newsletter
About 500 children aged 4 to 17, as well as 50 adults, participated in the study. Data was collected in 10 countries in North America and Europe. Participants were randomly assigned to receive either progressively increasing doses of AR101 or placebo; both were given as powders that could be mixed with food. People taking the active drug gradually increased their daily dose every two weeks. Once they took 300 milligrams a day, they maintained that dose for 24 weeks.
At the end of the study, approximately 67% of the 372 children taking the active drug were able to ingest 600 milligrams of peanut protein – the equivalent of two nuclei – without significant allergic symptoms, compared with only 4% of 124 children of the region. placebo group. And half of the children in the drug group could safely consume 1,000 milligrams of peanut protein – the equivalent of three or four nuclei – compared to about 2% of those in the placebo group. When they experienced allergy symptoms, children treated with AR101 experienced less severe reactions than their placebo group peers.
In adults, however, the differences between the two groups were less significant, suggesting that the drug might be more effective for children.
Although the results were promising, some people in the study still had severe allergic reactions. Almost 6% of active drug group members experienced "serious or serious adverse events" in the study, compared with almost 2% of those in the placebo group. None of these reactions were fatal or life-threatening, but 43 people in the drug group and three in the placebo group withdrew from the trial for reasons ranging from systemic allergic reactions to gastrointestinal symptoms. intestinal.
Next, the FDA will review the safety and efficacy data and decide whether to approve the drug or not. If the FDA agrees to Aimmune, the company says the treatment will be available on prescription by the end of 2019.
If it reaches this target, AR101 could be the first approved peanut allergy treatment on the market. Australian researchers have discovered last year that an association of immunotherapy and probiotics was allowing some peanut allergic children to safely eat peanuts, but no such treatment would bother them. " is currently available to consumers.
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