FDA approves peanut oral immunotherapy for toddlers
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Key takeaways:
- Palforzia is designed to protect patients with peanut allergy from reactions due to accidental exposure.
- 68.4% of toddlers tolerated at least 1,000 mg of peanut protein after 12 months of treatment.
The FDA has approved Palforzia for children aged 1 to 3 years who have a peanut allergy that has been diagnosed by a physician, according to a press release from its manufacturer, Stallergenes Greer.
Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp) is the first and only oral immunotherapy that mitigates anaphylaxis and other allergic reactions caused by accidental exposure, the company said.
In January 2020, the FDA approved Palforzia’s use for patients aged 4 to 17 years.
“We are delighted that Palforzia has received regulatory approval in the U.S. for toddlers, as there is a high unmet need for this age group,” Elena Rizova, MD, PhD, chief medical officer of Stallergenes Greer, said in the press release.
Stallergenes Greer noted that about 2% of the Western population is affected by peanut allergy, with prevalence doubling among children between 2005 and 2015.
Peanuts also are associated with higher rates of accidental exposure and severe reactions such as anaphylaxis, the company continued, adding that difficulties in avoiding peanut and in the severity of these reactions require effective treatment.
“We are confident that this indication extension will alleviate the burden of peanut allergy for younger patients and their families,” Rizova said.
Data from the international, randomized, double-blind, placebo-controlled phase 3 Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON) supported the FDA’s decision, Stallergenes Greer said.
POSEIDON included children aged 1 year to less than 4 years with a clinical history of peanut allergy. These children also had positive skinprick tests and/or elevated peanut antibody blood levels
Additionally, these children had dose-limiting symptoms following single doses of peanut protein ranging from more than 3 mg to 300 mg during double-blind, placebo-controlled food challenges (DBPCFC).
After an approximately 22-week dose-escalation period, participants reached daily doses of 300 mg of Palforzia (n = 98) or placebo (n = 48), which they continued for about 6 months, followed by an exit DPBCFC.
With no more than mild allergic symptoms during the exit challenge, 68.4% of the Palforzia group and 4.2% of the placebo group tolerated 1,000 mg of peanut protein or more.
Although the Palforzia group had more treatment-related adverse events, which the researchers classified as mild to moderate, Stallergenes Greer said treatment had a favorable safety profile.