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.[2][3][4] It is taken by mouth.[2][4]
| Clinical data | |
|---|---|
| Trade names | Palforzia |
| Other names | AR101, peanut allergen powder-dnfp, peanut (Arachis hypogaea) allergen powder-dnfp |
| AHFS/Drugs.com | Professional Drug Facts |
| License data | |
| Routes of administration | By mouth |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| PubChem SID | |
| DrugBank | |
| UNII | |
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.[2][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.[2][6] Peanut allergen powder should not be administered to those with uncontrolled asthma.[2][6]
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."[6][7] It is the first drug approved for treating peanut allergies.[8]
Medical uses
editIn the United States, peanut allergen powder is indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.[2][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.[4]
History
editThe 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.[6] 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.[6] 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.[6] The safety of peanut allergen powder was assessed in two double-blind, placebo-controlled studies in approximately 700 peanut-allergic individuals.[6]
In December 2018, Aimmune Therapeutics applied Biologics License Application for peanut allergen powder-dnfp to the US Food and Drug Administration.[7] In September 2019, the FDA Allergenic Products Advisory Committee decided seven to two in favor of the approval.[10] The final approval was issued in January 2020.[7]
Society and culture
editLegal status
editPeanut allergen powder was approved for medical use in the United States in January 2020,[2][6] and in the European Union in December 2020.[4]
The US Food and Drug Administration (FDA) requires a risk evaluation and mitigation strategy (REMS).[6] 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.[6]
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.[11] It was approved for medical use in the European Union in December 2020.[4]
Controversy
editAlthough 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.[10] 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]
References
edit- ^ "Palforzia - Summary of Product Characteristics (SmPC)". (emc). 15 July 2021. Archived from the original on 28 May 2022. Retrieved 24 March 2022.
- ^ a b c d e f g h "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. Archived from the original on 9 August 2024. Retrieved 13 August 2020.
- ^ a b "Palforzia". U.S. Food and Drug Administration (FDA). 7 February 2020. STN: 125696. Archived from the original on 13 February 2020. Retrieved 12 February 2020.
This article incorporates text from this source, which is in the public domain.
- ^ a b c d e f "Palforzia EPAR". European Medicines Agency. 13 October 2020. Archived from the original on 18 February 2022. Retrieved 24 March 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Palforzia Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
- ^ a b c d e f g h i j k "FDA approves first drug for treatment of peanut allergy for children". U.S. Food and Drug Administration (FDA) (Press release). 31 January 2020. Archived from the original on 1 February 2020. Retrieved 31 January 2020. This article incorporates text from this source, which is in the public domain.
- ^ a b c "Palforzia Approval Letter". U.S. Food and Drug Administration (FDA). 31 January 2020. Archived from the original on 26 December 2020. Retrieved 13 February 2020.
- ^ "The FDA has approved the first drug to treat peanut allergies". Science News. 4 February 2020. Archived from the original on 9 August 2024. Retrieved 13 February 2020.
- ^ "FDA Roundup: July 26, 2024". U.S. Food and Drug Administration (FDA) (Press release). 26 July 2024. Archived from the original on 9 August 2024. Retrieved 8 August 2024. This article incorporates text from this source, which is in the public domain.
- ^ a b Eiwegger T, Anagnostou K, Arasi S, Bégin P, Ben-Shoshan M, Beyer K, et al. (April 2020). "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. doi:10.1016/j.jaci.2019.10.021. PMID 31678426.
{{cite journal}}: CS1 maint: overridden setting (link) - ^ "Palforzia: Pending EC decision". European Medicines Agency (EMA). 16 October 2020. Archived from the original on 10 November 2020. Retrieved 16 October 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ Chu DK, Wood RA, French S, Fiocchi A, Jordana M, Waserman S, et al. (June 2019). "Oral immunotherapy for peanut allergy (PACE): a systematic review and meta-analysis of efficacy and safety". Lancet. 393 (10187): 2222–2232. doi:10.1016/S0140-6736(19)30420-9. PMID 31030987. S2CID 131777064.
{{cite journal}}: CS1 maint: overridden setting (link)
Further reading
edit- Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, et al. (The PALISADE Group of Clinical Investigators) (November 2018). "AR101 Oral Immunotherapy for Peanut Allergy". The New England Journal of Medicine. 379 (21): 1991–2001. doi:10.1056/nejmoa1812856. PMID 30449234.
{{cite journal}}: CS1 maint: overridden setting (link) - Bird JA, Spergel JM, Jones SM, Rachid R, Assa'ad AH, Wang J, et al. (2018). "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. doi:10.1016/j.jaip.2017.09.016. PMID 29092786.
{{cite journal}}: CS1 maint: overridden setting (link) - Allergenic Products Advisory Committee September 13, 2019 Meeting Transcript (PDF) (Report). U.S. Food and Drug Administration. Archived from the original on 1 February 2020. Retrieved 1 February 2020.
- Dufresne É, Poder TG, Bégin P (June 2020). "The value of oral immunotherapy". Allergy. 75 (6). Wiley: 1291–1293. doi:10.1111/all.14072. PMID 31579934.
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