Treatment with Peanut (Arachis hypogaea) Allergen Powder-dnfp (Palforzia) have begun for patients with peanut allergy in the United States, Aimmune Therapeutics announced Monday. Specialty pharmacies are shipping peanut allergen powder initial dosing kits to allergists for in-office administration to their patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy.1

Aimmune’s peanut allergen power was approved by the FDA on January 31, 2020, as an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. It is intended to be used in conjunction with a peanut-avoidant diet.1

In a conference call on Monday, Aimmune officials said they believe there is a sufficient supply of peanut allergen powder to meet the demand. Jayson Dallas, president and CEO, Aimmune, acknowledged supply concerns related to the novel coronavirus (COVID-19) but said there are no signs that the therapy will be rendered unavailable in the near future. He added that the product is entirely manufactured in the United States, from the sourced materials to the packaging.2

“We are continuing to be able to manufacture supply for the foreseeable future,” Dallas added in a press release.2

However, with the active COVID-19 pandemic, allergist and researcher Ellen Sher, MD, Allergy Partners of NJ, said physicians’ offices are limiting nonemergency visits with patients. “We haven’t booked anyone yet, but we do have a list of people,” she said, during the Aimmune conference call.2

According to Sher, a trial investigator, allergists are anticipating that care of patients using the peanut allergen powder will be covered with reimbursement. “I’m being told that its being covered by a lot of [insurance] plans, and that shouldn’t be an issue,” she said.2

In addition to the availability of peanut allergen powder, Aimmune announced new data that supports the product’s indication as an oral immunotherapy. According to Sher, the results of recent studies are “encouraging” and are consistent with other forms of allergy immunotherapy.2

According to Sher’s poster “Improved Tolerability and Continued Immunomodulation Among Subjects Aged 4–17 Years Following 28 or 56 Weeks of Extended Daily Therapeutic AR101 Dosing,” the research on peanut allergen powder showed an increase in the percentage of patients who tolerated higher doses of peanut protein than previous, shorter studies showed.

Sher, et al, also found an overall reduction in the number and rate of adverse events experienced, despite desensitization being incomplete during the first year of therapeutic dosing.3

“I think the data [are] really, really encouraging,” Sher said.2

Another study addressed quality of life for patients with peanut allergy receiving treatment with peanut allergen powder. This study, “Improvements in Self-Reported Disease-Specific Quality of Life Among Peanut-Allergic Subjects Receiving AR101 for 28 or 56 Weeks Beyond the First Year of Treatment,” found improvements in emotional and social quality of life after long-term treatment.4

Anna H. Nowak-Wegrzyn, MD, Hassenfeld Children’s Hospital at NYU Langone, said the improved tolerance has led to less stress about product labels and accidental exposures to peanuts.2

“This is a great relief that you can be protected against accidental exposure. This is a big deal to not have to be worried about cross-contamination,” she said.2

Both studies were to be presented at the 2020 American Academy of Allergy, Asthma & Immunology Annual Meeting,2-4 which was canceled due to concerns over the COVID-19 pandemic.5

Peanut allergen powder may only be administered to patients by allergists and allergy practices that have been certified under the risk evaluation and mitigation strategy (REMS) program.1

According to Aimmune officials, more than 600 allergists have been REMS-certified with more physicians expected to become certified in the program.1,2 “Their practices vary in size and in the number of patients being treated,” Dallas said in a virtual press conference held Monday. 2

Dispensing of peanut allergen powder also is limited to contracted pharmacies and distributors that will be certified in the REMS Program. Those pharmacies and distributors may only dispense this therapy to certified health care settings or to patients who are enrolled in the REMS program.1

The prescribing information for peanut allergen powder contains a boxed warning that the therapy can cause anaphylaxis, which may be life-threatening. Anaphylaxis can occur at any time during use of peanut allergen powder as a therapy. 1

In administering peanut allergen powder, injectable epinephrine must be prescribed. Patients should be instructed and trained on appropriate use of epinephrine and seek immediate medical care if used.1

According to Aimmune, the company will provide resources to patients and families who, upon consultation with their physician, wish to seek treatment with peanut allergen powder. Resources include educational materials, a dedicated call center, a co-pay program for eligible patients, and a patient assistance program to provide the therapy at no cost to eligible patients.1


REFERENCES
  1. Aimmune Announces First U.S. Patients Are Being Treated with Newly-Approved PALFORZIATM, the First Treatment for Peanut Allergy [news release]. Brisbane, CA; March 16, 2020: Aimmune Therapeutics website. http://ir.aimmune.com/news-releases/news-release-details/aimmune-announces-first-us-patients-are-being-treated-newly Accessed March 16, 2020.
  2. Aimmune Therapeutics. Conference Call. Presented: March 16, 2020.
  3. AAAAI Cancels the 2020 AAAAI Annual Meeting [news release]. Milwaukee, WI; March 8, 2020: AAAAI website. https://www.aaaai.org/Announcements/COVID-Mar-8 Accessed March 17, 2020.
  4. Siri D, Kachru R, Griffin N. Vereda A, Smith A, Sher E. Improved Tolerability and Continued Immunomodulation Among Subjects Aged 4–17 Years Following 28 or 56 Weeks of Extended Daily Therapeutic AR101 Dosing. Presented for: 2020 AAAAI Annual Meeting; March 13-16, 2020. http://ir.aimmune.com/static-files/17f6cbf1-2b99-4a18-a7f4-3d1ab1286e28 Accessed March 16, 2020.
  5. Ohayon J, Wang J, Griffin N, Vereda A, Smith A, Hourihane J. Improvements in Self-Reported Disease-Specific Quality of Life Among Peanut-Allergic Subjects Receiving AR101 for 28 or 56 Weeks Beyond the First Year of Treatment. Presented for: 2020 AAAAI Annual Meeting; March 13-16, 2020. http://ir.aimmune.com/static-files/a75425fe-3e8b-4285-9d54-ec54e3d92157. Accessed March 16, 2020.