Peanut allergen powder explained

Tradename:	Palforzia
Dailymedid:	Palforzia
Routes Of Administration:	By mouth
Atc Prefix:	None
Legal Uk:	POM
Legal Uk Comment:	^[1]
Legal Us:	Rx-only
Legal Eu:	Rx-only
Legal Eu Comment:	^[2] ^[3]
Drugbank:	DB10553
Unii:	QE1QX6B99R
Synonyms:	AR101, peanut allergen powder-dnfp, peanut (Arachis hypogaea) allergen powder-dnfp

Peanut allergen powder, sold under the brand name Palforzia, is an oral medication used for the treatment of children who have confirmed cases of peanut allergy.^[4] It is taken by mouth.^[5]

Peanut allergen powder is a powder that is manufactured from peanuts (Arachis hypogaea) and packaged in pull-apart color-coded capsules for dose escalation and up-dosing, and in a sachet for maintenance treatment.^[6]

The most common side effects of peanut allergen powder are abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath and anaphylaxis. Peanut allergen powder should not be administered to those with uncontrolled asthma.

In January 2020, the FDA approved the drug to Aimmune Therapeutics for mitigating "allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts."^[7] It is the first drug approved for treating peanut allergies.^[8]

Medical uses

In the United States, peanut allergen powder is indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.^[9]

In the European Union, peanut allergen powder is indicated for the treatment of people aged 4 to 17 years of age with a confirmed diagnosis of peanut allergy.

History

The effectiveness of peanut allergen powder is supported by a randomized, double-blind, placebo-controlled study conducted in the US, Canada, and Europe in approximately 500 peanut-allergic individuals. Effectiveness was assessed by evaluating the percentage of study participants tolerating an oral challenge with a single 600 mg dose of peanut protein (twice the daily maintenance dose of peanut allergen powder) with no more than mild allergic symptoms after six months of maintenance treatment. The results showed that 67.2% of peanut allergen powder recipients tolerated a 600 mg dose of peanut protein in the challenge, compared to 4.0% of placebo recipients. The safety of peanut allergen powder was assessed in two double-blind, placebo-controlled studies in approximately 700 peanut-allergic individuals.

In December 2018, Aimmune Therapeutics applied Biologics License Application for peanut allergen powder-dnfp to the US Food and Drug Administration. In September 2019, the FDA Allergenic Products Advisory Committee decided seven to two in favor of the approval. The final approval was issued in January 2020.

Society and culture

Legal status

Peanut allergen powder was approved for medical use in the United States in January 2020, and in the European Union in December 2020.

The US Food and Drug Administration (FDA) requires a risk evaluation and mitigation strategy (REMS). Peanut allergen powder is only available through specially certified healthcare providers, health care settings, and pharmacies to those who are enrolled in the REMS program.

In October 2020, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Palforzia, intended for desensitizing children and adolescents to peanut allergy.^[10] It was approved for medical use in the European Union in December 2020.

Controversy

Although the US Food and Drug Administration (FDA) had decided the approval of peanut allergen powder in 2019, the Institute for Clinical and Economic Review (ICER) reported that the clinical evidence is still insufficient.^[11] A 2019 systematic review and meta-analysis of twelve clinical trials consisting of 1041 cases questioned the safety of oral peanut allergen treatment. The study concluded that the treatments "increase allergic and anaphylactic reactions over avoidance or placebo, despite effectively inducing desensitisation."^[12]

Further reading

• Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, Jones SM, Shreffler WG, Marcantonio A, Zawadzki R, Sher L, Carr WW, Fineman S, Greos L, Rachid R, Ibáñez MD, Tilles S, ((Assa’ad AH)), Nilsson C, Rupp N, Welch MJ, Sussman G, Chinthrajah S, Blumchen K, Sher E, Spergel JM, Leickly FE, Zielen S, Wang J, Sanders GM, Wood RA, Cheema A, Bindslev-Jensen C, Leonard S, Kachru R, Johnston DT, Hampel FC, Kim EH, Anagnostou A, Pongracic JA, Ben-Shoshan M, Sharma HP, Stillerman A, Windom HH, Yang WH, Muraro A, Zubeldia JM, Sharma V, Dorsey MJ, Chong HJ, Ohayon J, Bird JA, Carr TF, Siri D, Fernández-Rivas M, Jeong DK, Fleischer DM, Lieberman JA, Dubois AE, Tsoumani M, Ciaccio CE, Portnoy JM, Mansfield LE, Fritz SB, Lanser BJ, Matz J, Oude Elberink HN, Varshney P, Dilly SG, Adelman DC, Burks AW . 6 . The PALISADE Group of Clinical Investigators . AR101 Oral Immunotherapy for Peanut Allergy . The New England Journal of Medicine . 379 . 21 . 1991–2001 . November 2018 . 30449234 . 10.1056/nejmoa1812856 . doi . free .
• Bird JA, Spergel JM, Jones SM, Rachid R, Assa'ad AH, Wang J, Leonard SA, Laubach SS, Kim EH, Vickery BP, Davis BP, Heimall J, Cianferoni A, MacGinnitie AJ, Crestani E, Burks AW . 6 . Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial . The Journal of Allergy and Clinical Immunology. In Practice . 6 . 2 . 476–485.e3 . 2018 . 29092786 . 10.1016/j.jaip.2017.09.016 . doi . free .
• Allergenic Products Advisory Committee September 13, 2019 Meeting Transcript . PDF . U.S. Food and Drug Administration . 1 February 2020 . 1 February 2020 . https://web.archive.org/web/20200201203513/https://www.fda.gov/media/132388/download . live .
• Dufresne É, Poder TG, Bégin P . The value of oral immunotherapy . Allergy . 75 . 6 . 1291–1293 . June 2020 . 31579934 . 10.1111/all.14072 . Wiley . vanc . doi . free .

Notes and References

1. Web site: Palforzia - Summary of Product Characteristics (SmPC) . (emc) . 15 July 2021 . 24 March 2022 . 28 May 2022 . https://web.archive.org/web/20220528220303/https://www.medicines.org.uk/emc/product/12197/smpc . live .
2. Web site: Palforzia EPAR . European Medicines Agency . 13 October 2020 . 24 March 2022 . 18 February 2022 . https://web.archive.org/web/20220218134932/https://www.ema.europa.eu/en/medicines/human/EPAR/palforzia . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
3. Web site: Palforzia Product information . Union Register of medicinal products . 3 March 2023 . 5 March 2023 . https://web.archive.org/web/20230305050230/https://ec.europa.eu/health/documents/community-register/html/h1495.htm . live .
4. Web site: Palforzia . U.S. Food and Drug Administration (FDA) . 7 February 2020 . 12 February 2020 . STN: 125696 . 13 February 2020 . https://web.archive.org/web/20200213072834/https://www.fda.gov/vaccines-blood-biologics/allergenics/palforzia . live .
5. Web site: Palforzia Initial Dose Escalation- peanut kit Palforzia (Level 1)- peanut powder Palforzia (Level 2)- peanut powder Palforzia (Level 3)- peanut kit Palforzia (Level 4)- peanut powder Palforzia (Level 5)- peanut powder Palforzia (Level 6)- peanut powder Palforzia (Level 7)- peanut kit Palforzia (Level 8)- peanut kit Palforzia (Level 9)- peanut powder Palforzia (Level 10)- peanut kit Palforzia (Level 11)- peanut powder . DailyMed . 14 February 2020 . 13 August 2020 . 9 August 2024 . https://web.archive.org/web/20240809000544/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=17f5be03-6705-4ac9-b8f3-bc4993ebc0eb . live .
6. FDA approves first drug for treatment of peanut allergy for children. 31 January 2020. U.S. Food and Drug Administration (FDA). 31 January 2020. 1 February 2020. https://web.archive.org/web/20200201011039/https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treatment-peanut-allergy-children. live.
7. Web site: Palforzia Approval Letter. 31 January 2020. U.S. Food and Drug Administration (FDA). 13 February 2020. 26 December 2020. https://web.archive.org/web/20201226021834/https://www.fda.gov/media/134857/download. live.
8. The FDA has approved the first drug to treat peanut allergies. 4 February 2020. Science News. 13 February 2020. 9 August 2024. https://web.archive.org/web/20240809000542/https://www.sciencenews.org/article/fda-first-drug-peanut-allergies. live.
9. FDA Roundup: July 26, 2024 . U.S. Food and Drug Administration (FDA) . 26 July 2024 . 8 August 2024 . 9 August 2024 . https://web.archive.org/web/20240809000550/https://www.fda.gov/news-events/press-announcements/fda-roundup-july-26-2024 . live .
10. Web site: Palforzia: Pending EC decision . European Medicines Agency (EMA) . 16 October 2020 . 16 October 2020 . 10 November 2020 . https://web.archive.org/web/20201110134942/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/palforzia . dead . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
11. Eiwegger T, Anagnostou K, Arasi S, Bégin P, Ben-Shoshan M, Beyer K, Blumchen K, Brough H, Caubet JC, Chan ES, Chen M, Chinthrajah S, Davis CM, Des Roches A, Du Toit G, Elizur A, Galli SJ, Håland G, Hoffmann-Sommergruber K, Kim H, Leung DY, Long A, Muraro A, Nurmatov UB, Pajno GB, Sampath V, Saxena J, Sindher S, Upton J, Worm M, Nadeau KC . 6 . Conflicting verdicts on peanut oral immunotherapy from the Institute for Clinical and Economic Review and US Food and Drug Administration Advisory Committee: Where do we go from here? . The Journal of Allergy and Clinical Immunology . 145 . 4 . 1153–1156 . April 2020 . 31678426 . 10.1016/j.jaci.2019.10.021 . doi . free .
12. Chu DK, Wood RA, French S, Fiocchi A, Jordana M, Waserman S, Brożek JL, Schünemann HJ . 6 . Oral immunotherapy for peanut allergy (PACE): a systematic review and meta-analysis of efficacy and safety . Lancet . 393 . 10187 . 2222–2232 . June 2019 . 31030987 . 10.1016/S0140-6736(19)30420-9 . 131777064 .