Palforzia cannot cure peanut allergies, but it can be used for severe peanut allergy treatment and to make all reactions to peanuts less severe. This process occurs by gradually decreasing the sensitivity of the immune system to small amounts of peanuts that could be hidden in foods. The goal is to increase the threshold required to trigger an allergic reaction.
Palforzia is an oral peanut protein powder that should be mixed with food prior to consumption by a patient with confirmed peanut allergy. After handling Palforzia, you should wash your hands immediately to avoid spreading any peanut product around your home. Monitor for any potential reactions after taking Palforzia.
Safety and Effectiveness Information
Oral immunotherapy (OIT) with Palforzia can lead to desensitization in some children with confirmed peanut allergy. However, the ability of Palforzia to induce peanut tolerance is unclear, as is the case with other existing OITs.
US FDA approval of Palforzia was based upon the largest trial study of peanut allergen oral immunotherapy to date, which included 499 children aged 4 to 17 years and 56 adults aged 18 to 55 years. Of the children on active treatment, 77% tolerated the once daily 300 mg maintenance dose of peanut protein with no more than mild symptoms during a peanut challenge at the end of the study. Meanwhile, only 4% of the children in the placebo group passed the peanut challenge.
The rate of serious adverse events during the study was higher for the group receiving Palforzia treatment compared to the placebo group. For example, epinephrine administration for anaphylaxis was at 14% for active treatment patients compared to 6% for the placebo group. Patients on Palforzia were able to better tolerate peanut exposure during a food challenge, but they also had higher rates of anaphylaxis.
Despite the increased risk of anaphylaxis and other adverse effects, some patients may be highly motivated to take an oral immunotherapy such as Palforzia to help alleviate the anxiety of experiencing a severe allergic reaction in public upon accidental peanut ingestion. You should have a discussion with your allergist to determine if you are a good candidate for Palforzia. If a patient with confirmed peanut allergy already has a threshold high enough to make accidental ingestion reactions unlikely, he or she may be a poor candidate for Palforzia. Additionally, adverse effects, risk for anaphylaxis, and daily commitments required of oral immunotherapy may outweigh any potential benefit of Palforzia in increasing the allergic reaction threshold.
When examining the combined data of 12 clinical trials totaling 1041 patients, peanut OIT was 12 times more effective at increasing the likelihood of passing a supervised food challenge than an elimination, peanut-avoidant diet alone. However, the risk of anaphylaxis during the maintenance phase was 3 times higher for patients receiving peanut OIT treatment. Patients receiving peanut OIT also had higher frequencies of vomiting and other gastrointestinal symptoms.
Limited data suggests that OIT may be better tolerated and perhaps more effective in young children than it is in older children. In a prospective study of 40 young children (ages 9 to 36 months) treated with either high- or low-dose peanut OIT (300 mg or 3000 mg peanut protein), both groups demonstrated high rates of short-term sustained unresponsiveness (78 percent overall). Nearly all patients experienced mild or moderate adverse events, but serious adverse events were not reported.
Individuals with uncontrolled asthma, history of eosinophilic esophagitis, or history of other eosinophilic gastrointestinal disease should not take Palforzia. In general, Palforzia may be unsuitable for patients with conditions that reduce their ability to survive anaphylaxis. These conditions include compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, you should not start therapy with Palforzia if you had a severe or life-threatening anaphylaxis in the previous 60 days.
FAQs
“We are proud that the Trust is the first in the country to offer this treatment – with special thanks to the young patients and their families that took part in the ARTEMIS trial to get us to this point.” The first PALFORZIA clinics took place this week at the James Paget, on 9 June 2022.
Does palforzia cure peanut allergy? ›
And although PALFORZIA is not a cure for peanut allergy, it can help make your child's reaction to accidental exposure less severe. Note that if your child turns 18 years of age while on PALFORZIA treatment, they should continue taking it unless otherwise instructed by a doctor.
What is 300 mg Palforzia equivalent to? ›
Palforzia dosing is standardized, starting at the same small amount and increasing on the same schedule to a final daily maintenance dose of 300 mg peanut protein, roughly equal to one peanut kernel, which is lower than most peanut OIT maintenance doses.
What is the best peanut allergy treatment? ›
Palforzia is the only oral immunotherapy product currently approved by the FDA for treatment of peanut allergy. This type of treatment is called oral peanut immunotherapy. It slowly exposes an allergic child to peanuts so their immune system is less likely to react after an accidental ingestion of peanut product.
How do I get prescribed Palforzia? ›
To get started, talk to an allergist about PALFORZIA. It is only available through the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program with a certified healthcare provider. If your child's allergist is not REMS-certified, they can get certified. To learn more, visit PALFORZIAREMS.com.
How much is palforzia without insurance? ›
The cost for Palforzia oral powder 300 mg is around $625 for a supply of 15 powder, depending on the pharmacy you visit.
Can you eat peanuts after palforzia? ›
PALFORZIA can help reduce the severity of allergic reactions after exposure to peanut. PALFORZIA is not effective against any other nut or food allergies. Patients who are taking PALFORZIA should continue to avoid eating peanuts.
How successful is peanut allergy treatment? ›
Of the 54 peanut-allergic children participating in the study, 47 completed the treatment, with 70% showing protection against accidental exposures of peanut (>800 mg peanut, ~3 peanuts) and 36% showing full desensitization (5000 mg of peanut, ~16 peanuts).
Will peanut allergies ever be cured? ›
There is no cure for peanut allergies. Palforzia is a type of oral immunotherapy that is approved for use in treating peanut allergies. It contains precise amounts of peanut protein and is given to children age 4-17 years of age every day to help decrease their sensitivity to small amount of peanuts over time.
Will Palforzia be available for adults? ›
Palforzia is for use in adults and children at least 4 years old who have been diagnosed with an actual peanut allergy. Palforzia will not affect allergic reactions to other foods. Always seek emergency medical attention if you have an allergic reaction. Palforzia is available only under a special program.
Provider must get REMS certified before they can prescribe PALFORZIA. Before receiving treatment, your child also needs to be enrolled in the REMS program by your child's certified allergist—who can tell you more about this program and help your child enroll. Visit PALFORZIAREMS.COM for more information.
What are the side effects of Palforzia? ›
What are the possible side effects of PALFORZIA? The most commonly reported side effects were stomach pain, vomiting, feeling sick, itching or burning in the mouth, throat irritation, cough, runny nose, sneezing, throat tightness, wheezing, shortness of breath, itchy skin, hives, and/or itchy ears.
How much does peanut immunotherapy cost? ›
The costs of immunotherapy with AR101 and Viaskin Peanut were unknown at the time of the public meeting. Based on analyst estimates, we assumed placeholder costs of $4,200 per year for AR101 and $6,500 per year for Viaskin Peanut. Trial-reported quality of life outcomes have not yet been published.
What are the new treatments for peanut allergies? ›
SLIT is a treatment using a tiny amount of peanut protein that is the equivalent of only 1/75th of a peanut kernel. It is taken under the tongue, where it is absorbed into the body, as opposed to Palforzia® peanut oral immunotherapy, which requires patients to eat a medical grade peanut flour each day.
What percentage of peanut allergies go away? ›
Studies show that an estimated 20–25% of children experiencing a peanut allergy will outgrow it. Of those that outgrow their allergy, 80% do so by the age of eight. While this data offers relief to many parents, it still means a large proportion of individuals will need to manage their condition.
When will HypoCat vaccine be available? ›
The HypoCat vaccine may be available in the United States by 2024. Resources: The Journal of Allergy and Clinical Immunology. Immunization of cats to induce neutralizing antibodies against Fel d 1, the major feline allergen in human subjects.
Can adults get palforzia? ›
PALFORZIA contains peanut protein from defatted powder of peanut seed. It is a treatment for people who are allergic to peanuts (Arachis hypogaea L.). PALFORZIA is intended for children and adolescents aged 4 through 17 years and those who become adults whilst on treatment.
