Peanut allergy is harmless to some, but far from a big deal to others. Around 2% of children have allergies to peanuts, one of eight recognized staple food allergens.
In January 2020, before Covid, the FDA approved a drug to treat peanut allergies in children. Called Palforzia, it is not a traditional drug, but a “peanut allergen powder” made from peanut powder and peanut protein. Palforzia conditions the immune system to tolerate peanuts in very small doses over three phases of administration. However, this carries the risk of allergic reactions during treatment. Of 709 treated study participants, severe reactions were reported in 9.4% of the participants in the first two phases, in contrast to almost 4% of the 292 untreated participants. The children in the placebo group were not exposed to peanuts.
Palforzia is approved for children aged 4 to 17 years. Treatment is divided into three phases: “Escalation of the initial dose”, “High dose” and “Maintenance dose”. The first two phases last about a year and must be done under the supervision of a doctor, as allergic reactions, some of which are serious, are possible side effects. The last phase can be done at home.
The pandemic delayed the introduction of the therapy. Unless essential services were hired, patients could not reach their allergy sufferers for treatment. Now allergy sufferers have started taking in patients again. According to the Palforzia website, this therapy is only available through a risk assessment and reduction strategy program as this therapy can cause severe allergic reactions. Doctors must complete the program with the therapy manufacturer, Aimmune, before they can prescribe it to patients. So far there are around 1,000 certified allergists.
A short story
Treatments of this type are known as oral immunotherapy. It’s not a new idea. According to The Atlantic, attempts to treat people with peanut allergies with a dash of peanut extract were tried in the 1990s. One patient died during these attempts.
Palforzia has been shown to be safe in its clinical studies and therefore received FDA approval. At the end of Palforzia’s clinical trial, two-thirds of those who received the treatment were able to eat two whole peanuts.
Tackling peanut allergies is about more than just consuming PB & Js without fear of hospitalization. Undeclared peanuts – when peanuts are in a product, but peanuts are not listed on the label – will appear in all types of products. In 2020, the FDA recalled 24 products due to possible peanut contamination or undeclared peanut contamination. They showed up in granola bars, ice cream, yogurt-coated pretzels and raisins, and even probiotics.
The FDA estimates that of the 1 million children in this country who have a peanut allergy, perhaps 20% will outgrow it. Deaths from food allergies are relatively rare.
This peanut allergen powder should not be used to treat the life-threatening condition called anaphylaxis, which is the most serious allergic reaction. In October, the World Allergy Organization defined anaphylaxis as “a serious systemic hypersensitivity reaction that usually sets in quickly and can lead to death. Severe anaphylaxis is characterized by potentially life-threatening compromises in airways, breathing and / or circulation and can occur without typical skin features or circulatory shock. “
Patients should avoid peanuts while being treated with Palforzia.
Aimmune, which makes Palforzia, has some competition. The French biopharmaceutical company DVB Technologies has made Viaskin, a patch for people with peanut allergies. Last year Viaskin was denied FDA approval because it cited problems with the adhesive patch itself. The company is still working on Viaskin but laid off nearly 200 employees earlier this year. According to DVB, the cost savings from these dramatic downsizing will keep the company open until 2022.
Even if Palforzia receives FDA approval, there is still no deadline for allergy sufferers. The first year of Palforzia treatment must be under the supervision of a doctor, as anaphylaxis or anaphylactic reaction are possible side effects of Palforzia treatment that usually occur during these phases. With Covid-19 forcing non-essential businesses to close and flooding the medical system, patients were unable to get to allergy clinics, delaying the rollout of Palforzia.
It wasn’t all bad news. As soon as the doctor’s offices began to reopen, Aimmune began enrolling. 1,000 doctors had registered by July. “The company is seeing some clinics starting to fully operationalize Palforzia on a large scale with double-digit new patient starts,” it said in a statement.
At the end of December, the European Commission approved the therapy.
The future of allergy treatment
In October, Aimmune was acquired by Nestlé – Nestlé Health Science. But yes, his parent makes the chocolate chips wrapped in yellow.
According to Aimmune filing with the Securities and Exchange Commission, Palforzia will cost $ 890 per month, although assistance is available for some families, bringing the cost down to $ 20.
The first two stages of treatment with Palforzia last almost a year, so Palforzia patients should be able to move into the maintenance phase in the first half of 2021. In the future, Aimmune plans to expand its treatment to infants (under 4 years old) and adults, and to include other allergies.