New Peanut Allergy Treatment Nears FDA Approval
Peanut oral treatments have been in the works for a while. From clinical trials to more trials, one drug seems to be breaking through and getting to market. On September 13th, an expert advisory panel that works with the Food and Drug Administration voted for the approval of Palforzia, a new treatment option for children with peanut allergies. Typically, the FDA follows the recommendation of the advisory panel. What is this treatment and what does it mean for the future of peanut allergy treatments?
What is Palforzia?
Formally known as AR101, Palforzia is a brand named oral immunotherapy treatment. It is designed to treat children between the ages of four to seventeen. Palforzia is not a cure for peanut allergies, but a treatment. Like other oral immunotherapies, Palforzia introduces controlled small amounts of peanut flour to the child.
Palforzia’s most recent trial produced decent results. Out of 554 patients, 93% tolerated 300-mgs of peanut protein, with 84% tolerating 600-mgs and 63% tolerating 1000-mgs. On average, one peanut contains 180 to 200 mg of peanut protein.
Like lots of treatments, there are side effects. Roughly 14% of patients experienced systemic hypersensitivity reactions. Of those reactions, 92% were classified as mild or moderate. Sadly, the study showed there was almost triple the risk of anaphylactic reactions while taking Palforzia.
What’s the Future for Palforzia?
Palforzia is the first standard version of oral immunotherapy that’s aiming for FDA approval. While the vote on Palforzia isn’t until next year, many experts are concerned. Dr. John Kelso, an allergy specialist, said “I think from the data that we have had presented to us that neither the safety nor efficacy have been demonstrated.” While oral immunotherapies like Palforzia do treat peanut allergies, they do not translate into less anaphylaxis over time.
The FDA stated that if Palforzia was approved, it would only be done so by carefully regulating its use. Any patient on Palforzia would need to have a supply of epinephrine and take their first dose in a clinic.
If Palforzia is approved, talk with your allergist before deciding to take Palforzia. The treatment does have a lot of risks and side effects. It depends mainly on how your child fares on strict avoidance of peanuts normally.
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