Clarissa Chan, PharmD
Palforzia (peanut allergen powder-dnfp–Aimmune Therapeutics), which was FDA-approved in 2020, has been giving people with peanut allergies protection from severe reactions. By using novel, medical-grade peanut (Arachis hypogaea) powder, Palforzia ensures consistent, accurate dosing of the allergic protein following strict treatment protocols.
Pharmacy Today asked Erin Malawer, executive director of AllergyStrong and cofounder of the Food Allergy Collaborative, to discuss Palforzia and its impacts on the future of patients with peanut and other food allergies.
Future horizons
According to FDA, Palforzia is both safe and effective for desensitizing patients to peanuts.
“Palforzia offers patients and their caregivers relief in knowing they have some level of protection in reducing the incidence and severity from accidental exposure to peanuts, which is the primary goal of OIT [oral immunotherapy],” said Malawer. “We call this accidental exposure ‘bite-safe’ protection.”
Since Palforzia is the only FDA-approved treatment for peanut allergies, insurance companies are more likely to cover costs associated with Palforzia versus off-the-shelf OIT. Coverage extends the reach of treatment to patients who otherwise cannot afford it, Malawer said.
Palforzia is changing the landscape for those living with food allergies, said Malawer. “It’s the gateway for future food allergy treatment approval,” she said. “Those with food allergies need more treatment options to fit the allergies, stage of life, and lifestyle they live with, and FDA’s approval of Palforzia is the first step in that direction.”
In the pipeline
Researchers are studying many different treatment avenues to lessen the burden of food allergies, including approaches through the microbiome and skin, various oral immunotherapies (oral, oral mucosal, sublingual), and even injectable peanut vaccines.
Patients have expressed interest in therapies that go beyond the peanut and those with long-lasting results. The future of food allergy treatment is encouraging, but a cure is still needed, Malawer said.
“Epicutaneous immunotherapy—also known as the ‘peanut patch’—has shown promising results recently,” Malawer said. “Worn as a patch, patients absorb peanut protein through the skin and build tolerance that way.”
Additionally, developing a low level of tolerance may allow some patients’ food purchasing to include food with precautionary labels like “made in a facility with…” or “may contain,” she said.
Potential concerns
Malawer worries that parents, caregivers, and patients may think that undergoing OIT will allow them to freely eat their allergen upon completion of treatment. Health care providers and advocacy organizations need to clearly and consistently communicate and establish realistic expectations about treatment end goals and what “bite-safe protection” really means, said Malawer.
Palforzia competes with off-the-shelf OIT. While Palforzia offers a measured and regulated path to bring patients to bite-safe levels of protection, it must also provide revenue to health care practices. “Some physicians claim they can achieve higher levels of tolerance with off-the-shelf OIT and cite the cost of Palforzia as a hindrance,” Malawer said.
How pharmacists can inform patients
As pharmacists process epinephrine autoinjector prescriptions, they may discover their patients have food allergies. It is important for pharmacists to collaborate with allergists and to counsel patients about Palforzia and its use, Malawer said.
“Correct use of this product is critical, as mistakes could lead to anaphylaxis,” said Malawer. “Pharmacists’ careful review of protocols and reinforcing providers’ instructions will help ensure Palforzia is dosed properly.”
Pharmacists can also help patients think through their food allergy needs as they undergo OIT. They can make sure patients have a current epinephrine prescription, and remind them to keep it at room temperature and to carry a set with them at all times, Malawer said.
Other considerations since the launch of Palforzia
Many people with multiple food allergies await treatment, risking accidental food allergy reaction if exposed to their allergen.
“It will be important to develop a standardized, Palforzia-like product for other allergens, as peanuts are only one of the nine most common allergens,” said Malawer. “We also need treatments that are effective at protecting adults with other food allergies, as they comprise about 26 million of 32 million Americans living with food allergies today.”
Nasal epinephrine is presently pending FDA approval. Since epinephrine is currently only available by intramuscular injection, many patients fail to fill their prescription or use their epinephrine autoinjector prescriptions when needed due to their fear of needles, Malawer said.
“Nasal epinephrine delivery devices will be smaller and easier to carry (and needle-free), reducing the barrier to use in a timely way. This will ultimately save lives,” said Malawer. ■