Not many allergists are mourning the exit of the first and only FDA-approved oral immunotherapy (OIT) product — peanut allergy treatment Palforzia — from the market.
The standardized peanut protein product had been approved for treating peanut allergy in kids ages 4 to 17 years in 2020 but was discontinued in July. Manufacturer Stallergenes Greer said that safety, quality, and effectiveness weren’t to blame for the business decision.
Uptake was low, allergist-immunologist David M. Fleischer, MD, of the University of Colorado Anschutz, told MedPage Today.
“I just don’t know if it was ever a model that was going to work,” he said. The discontinuation is “not going to affect my day to day, and I don’t think it’s affected most practices that are doing OIT. They were already going to continue with their own peanut products that they’re comfortable with.”
Questionable Need
When Palforzia was developed, clinicians already had decades of experience using peanut OIT with grocery-store peanut food products: peanut kernels, peanut butter, freeze-dried peanut butter, freeze-dried peanut kernels, peanut-containing candies, and peanut-containing puffs.
The branded product demonstrated less variability in peanut protein content — a 1% relative standard deviation compared with 2% to 18% across the grocery-store products in one study — which could be important for safety, especially at the low doses used early in OIT.
Anaphylaxis can occur when allergic children are given the small doses of their allergic food for OIT, and particularly during dose escalation. If the child gets a larger dose than expected due to product variation, there’s greater potential for anaphylaxis.
However, even with the standardized product, the non-negligible risk of anaphylaxis reactions meant that physicians had to participate in Palforzia’s Risk Evaluation and Mitigation Strategy (REMS) Program to prescribe it. That administrative hurdle along with the need to obtain prior authorization and its higher price point compared with grocery-store peanut products made it less attractive, Fleischer said.
“Are they going to use something that could be a lot more expensive and a lot more work to do for a well-characterized product that we already have?” he posited. “It just is a lot of extra work that practices probably didn’t want to do or feel they needed to do because they were already comfortable using a product that’s off the shelf.”
The same is true for egg, sesame, tree nut, and other food allergies for which practices have been using off-the-shelf products for OIT, he noted.
“If we had to wait and try to get something FDA approved for [all of the allergens], imagine the amount of money to do that, first of all,” Fleischer said. “And again, it’s proven that it’s not necessary to do that because we can use other products that people have been using for 20, 30 years doing OIT in clinical practice.”
However, according to the Allergy and Asthma Network, insurance might not pay for treatments that aren’t FDA approved.
What’s Ahead
There’s a lesson to be learned for the potential development of other products to replace allergen treatments already in use. “I worry about sublingual tablets going down the same path potentially, because other practices are doing sublingual immunotherapy with real food,” Fleischer said.
Nevertheless, innovation is moving forward.
A peanut epicutaneous immunotherapy patch (Viaskin) passed phase III testing and is expected to be under review by the FDA for approval before the end of the year, which could find a place as a “super safe, very practical option for patients,” Fleischer said. An oral nanoparticle vaccine for peanut allergy and a neutralizing antibody for peanut allergy are also being studied.
“Oral immunotherapy is not for everyone. It’s got restrictions on exercise, and you have to be careful with illness and all those things,” Fleischer said. “I want to have six to eight, 10 tools in my toolbox to use as options for patients.”
Editor’s note: Reference to the peanut immunotherapy patch has been corrected to indicate an epicutaneous rather than transdermal route of administration.
Disclaimer: The information provided does not constitute medical advice and is for informational purposes only. Always consult a healthcare professional for personal medical advice.
Fuente: https://www.medpagetoday.com/allergyimmunology/allergy/122635
Join the doctors who get the most relevant medical news, curated by specialty, every week — no spam, unsubscribe anytime.
