FDA Approves First Drug for Children’s Peanut Allergies

The FDA has approved a drug called Palforzia, the first to treat allergic reactions to peanuts in children. The drug, which must be taken daily, isn’t a cure for peanut allergies and their potentially life-threatening reactions, but it may reduce the stress, anxiety, and fear that food allergies can cause in children and parents.

Palforzia, developed by a California startup called Aimmune Therapeutics, is a regimen called oral immunotherapy. The drug must be taken daily in increasing doses of peanut protein to reduce the immune system’s reaction to peanuts.

The drug is a powder made from peanuts and packaged in color-coded capsules. The powder is emptied into semi-solid food like yogurt and consumed with a goal of training the immune system to respond differently to a substance that causes allergic reactions.

The new drug is not designed as a preventative measure or emergency treatment for peanut exposure. Instead, it’s designed to mitigate the effects of the immune system’s response. An epinephrine auto-injector should still be kept close at hand to stop a severe or life-threatening allergic reaction.

Almost 8,000 people have received Palforzia over the last decade. Palforzia has been proven effective in many patients with some able to consume small amounts of peanuts in food that would previously have caused dangerous reactions.

The Dangers of Peanut Allergies

One in 13 children now have food allergies and peanut allergies are among the most common causes of severe, life-threatening allergy attacks. While 1.2 million teenagers and children in the United States have peanut allergies, it isn’t known what causes the immune system’s overreaction. About 1 in 5 children outgrow their allergy.

For reasons unknown, peanut allergies are on the rise. The prevalence of peanut allergies tripled between 1997 and 2008 with a further surge since. For years, expectant and nursing mothers were advised to avoid peanuts as it was believed early exposure could sensitize infants to a serious peanut allergy, although this did nothing to stop the rise of peanut allergies and the advice has since been abandoned. It’s now believed that the opposite is true: early exposure to peanut protein may induce tolerance instead.

In children who are allergic to peanuts, accidental exposure can cause unpredictable and potentially severe allergic symptoms such as skin rashes, airway constriction, and even loss of blood flow to organs.

Peanut allergies are tricky because peanuts are found in many foods and appear in trace amounts with other ingredients. For some highly sensitive children, even skin exposure or inhaling peanut dust can cause reactions.

New research suggests it may be possible to prevent a peanut allergy, especially in young children who are at high risk, have eczema, or have other food allergies. The National Institute of Allergy and Infectious Diseases recommends introducing peanut-containing foods during the first 4 to 6 months of life to possibly prevent an allergy.

A Treatment Not Without Risk

The drug is now FDA-approved for children 4 to 17 years old who have a peanut allergy and it can be used by adults. Despite the celebration over the approval, Palforzia is not a cure for peanut allergies, it does not work for all children, and it comes with side effects.

Potential side effects of Palforzia are similar to allergic reactions and may include abdominal pain, nausea, vomiting, tingling sensations in the mouth, throat tightness, cough, runny nose, wheezing, shortness of breath, hives, and anaphylaxis.

Palforzia is administered in three phases. Treatment begins with an initial dose escalation of one dose given in a single day. Next is the up-dosing phase which occurs over a period of months as patients take 11 increasingly higher doses at home and receive monitoring by a certified allergists. The final phase is a maintenance period.

Anaphylaxis is a life-threatening reaction and it may occur during any stage of Palforzia treatment, although the risk is highest during and after the initial dose escalation and the first dose of every up-dosing level.

Immunotherapy: A Century-Old Practice

While many parents are celebrating the news of Palforzia’s approval, some critics say it’s merely an expensive form of immunotherapy that has been in use for more than a century.

Some allergists and allergy sufferers already do a similar form of oral immunotherapy with prescribed doses of peanut flour which is also the main ingredient in Palforzia’s capsules. While a bag of peanut flour may last an allergist a year treating patients, a year’s supply of Palforzia is estimated to cost $4,200 per person, according to analysts.

Still, other allergists believe a standardized product with measured allergens can provide safer and more predictable treatment. With store-bought substances, there is no way to be sure how much allergen a patient has received as commercial products vary a great deal in the amount of peanut proteins.

Research already seems to show that at-home microdosing of peanuts to treat peanut allergies may do more harm than good. In one study published in The Lancet, researchers examined data from 1,000 subjects over 12 separate studies. They found the risk for anaphylaxis climbed from 7.1% to 22.2% after exposure to microdosing therapy compared to a placebo. Patients in the oral immunotherapy studies also had higher rates of epinephrine use and more frequent non-anaphylactic reactions such as nausea.