New Peanut Allergy Drug Palforzia Approved by the FDA

The U.S Food and Drug Administration (FDA) announced the approval of the peanut allergy drug Palforzia on January 31, 2020.

The drug is approved to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. The drug is approved for people ages 4 through 17 with a diagnosis of peanut allergy.

Palforzia can be life-changing for people willing to commit to taking the therapy as directed, says Sandra Hong, MD, director of the Food Allergy Center at Strongsville Family Health Center in Ohio, part of the Cleveland Clinic Health System. “It actually gives patients a chance to just live without the anxiety of accidental exposure,” says Dr. Hong.

This is the first FDA-approved treatment ever for food allergies, which is pretty incredible, notes Hong. “Previously, if you accidentally came into contact with peanuts and had a bad reaction, you used epinephrine and went to the ER. Now there is a true therapy that could prevent that person from having a life-threatening reaction later on in life,” she says. This is really exciting for the allergy world and for people with food allergies, adds Hong.

"Peanut allergy affects approximately 1 million children in the United States, and only 1 out of 5 of these children will outgrow their allergy,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement released by the agency.

“When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy,” said Dr. Marks.

Palforzia Can Protect Patients From an 'Accidental Bite'

The approval was made on the basis of a randomized, double-blind, placebo-controlled study of more than 500 people who were allergic to peanuts. The patients were evaluated after six months of maintenance treatment, and success was measured by the percentage of participants who could tolerate an oral challenge with a single 600 milligram dose of peanut protein, the equivalent to two peanuts.

About 2 out of 3, or 67.2 percent of people taking Palforzia tolerated the 600 milligram dose compared with 4 percent of the placebo group.

Although taking Palforzia still means avoiding peanuts, the drug can mean more peace of mind for children and parents who live in fear of accidental exposure, says Hong.

“It can take significantly less than a single peanut. It can take a lick of a peanut to trigger a life-threatening anaphylactic reaction for some individuals who are highly allergic,” she says.

This exposure can happen even if the food doesn’t contain peanuts at all, explains Hong. “It could happen by accidentally eating a bite a bread from a loaf that was placed on the same countertop as a peanut butter cookie,” she says.

“If a person was taking this medication, they can potentially take a bite of that bread and not have a reaction, whereas previously that might have sent them to the emergency room or the intensive care unit,” says Hong. “Now they don’t have to have that fear all the time.”

How the Allergy Drug Works

Palforzia is a powder made from peanuts. It doesn’t “cure” a peanut allergy, but instead decreases the frequency and severity of an allergic reaction by a process called immunotherapy.

In the allergy world, immunotherapy involves actually exposing a person to increasing doses of the substance or allergen that they are allergic to — in this case, peanuts.

“People are given tiny, tiny amounts over a period of time such that the body just doesn’t see it as foreign anymore. If you’ve ever heard of someone with allergies or asthma being on allergy shots, that’s the same idea,” says Hong.

Beginning treatment with Palforzia is not as simple as taking a pill once or twice a day. It involves three phases: initial dose escalation, up-dosing, and maintenance, according to the prescribing information.

The initial dose escalation is spaced out over a single day and involves five gradually increasing doses of Palforzia. The next phase, up-dosing, consists of 11 increasing dose levels over the course of several months. The initial escalation and the first dose of each up-dosing level are administered under supervision at a healthcare facility.

After successfully completing all the up-dosing levels, the patient graduated to the daily maintenance dose. Typically, if you miss multiple doses it puts you at risk of having a reaction because your body gets used to that amount; and if you stop it all of a sudden, it goes back to square one, according to Hong. “This medication is meant for a family who can be very, very compliant and be able to take the medication every single day,” she says.

Because of the risks and complexity of the dosing, Palforzia can only be prescribed through a restricted program called Palforzia Risk Evaluation and Mitigation Strategy (REMS). The patient must be enrolled in the program; and the patient, parent, or guardian must be educated by a healthcare provider who has enrolled in the program. Patients will be taught how to monitor themselves with the initial dose escalation procedure as well as first dose of each up-dosing level.

The REMS is completely appropriate because of the risks and education necessary, says Hong. “Families won’t change what they were doing before. They will still carry epinephrine with them, and they’ll still continue to ask if foods contain peanuts,” she says.

It is important to have these risk-mitigating practices because there are certain things that patients and families need to know, according to Hong. For example, exercise or a fever might trigger an allergic reaction, and so being aware of that risk in order to properly time or withhold the medication is important, she adds.

The education also includes how to recognize the signs and symptoms of anaphylaxis, and injectable epinephrine must be available to the patient for immediate use at all times.

During the initial up-dosing and dose escalation in clinical trials, 9.4 percent of Palforzia-treated patients reported anaphylaxis compared with 3.8 percent of placebo-treated subjects. During the maintenance phase, 8.7 percent of people taking Palforzia experienced anaphylaxis compared with 1.7 percent of people taking the placebo.

Peace of Mind Comes at a Cost

The list price for the drug is $890 a month, or about $11,000 a year. According to a statement released by Aimmune Therapeutics, the company that makes Palforzia, there will be a copay program for eligible patients as well as a patient assistance program to provide Palforzia at no cost to eligible patients.

Right now, Palforzia is the only drug available for peanut allergies, but it’s expected to be joined soon by Viaskin Peanut, manufactured by DBV Technologies. The immunotherapy drug was granted Breakthrough Therapy and Fast Track designation from the FDA in 2012 and 2015 but has not yet been approved. According to a statement by DBV, the company hopes to work with the FDA to potentially bring the drug to market in the second half of 2020.

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