Peanut allergen powder, sold under the brand name Palforzia, is an oral

immunotherapy Immunotherapy or biological therapy is the treatment of disease by activating or suppressing the immune system. Immunotherapies designed to elicit or amplify an immune response are classified as ''activation immunotherapies,'' while immunotherap ...

used for the treatment of children who have confirmed cases of

peanut allergy Peanut allergy is a type of food allergy to peanuts. It is different from tree nut allergy, tree nut allergies, because peanuts are legumes and not true Nut (fruit), nuts. Physical symptoms of allergic reaction can include pruritus, itchiness, h ...

. It is taken

by mouth Oral administration is a route of administration whereby a substance is taken through the Human mouth, mouth, swallowed, and then processed via the digestive system. This is a common route of administration for many medications. Oral administ ...

. Peanut allergen powder is a powder that is manufactured from

peanut The peanut (''Arachis hypogaea''), also known as the groundnut, goober (US), goober pea, pindar (US) or monkey nut (UK), is a legume crop grown mainly for its edible seeds. It is widely grown in the tropics and subtropics by small and large ...

s (''Arachis hypogaea'') and packaged in pull-apart color-coded capsules for dose escalation and up-dosing, and in a sachet for maintenance treatment. The accurate dosing of the pharmaceutical product allows use by people with allergies extreme enough to be seriously affected by a few milligrams too much. 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 Hives, also known as urticaria, is a kind of skin rash with red or flesh-colored, raised, itchy bumps. Hives may burn or sting. The patches of rash may appear on different body parts, with variable duration from minutes to days, and typically ...

, wheezing and shortness of breath and anaphylaxis. Peanut allergen powder should not be administered to those with uncontrolled

asthma Asthma is a common long-term inflammatory disease of the airways of the lungs. It is characterized by variable and recurring symptoms, reversible airflow obstruction, and easily triggered bronchospasms. Symptoms include episodes of wh ...

. 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." It is the first drug approved for treating peanut allergies.

Medical uses

In the United States, peanut allergen powder is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. 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 The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(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 The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

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. It was approved for medical use in the European Union in December 2020.

Controversy

Although the US

(FDA) had decided the approval of peanut allergen powder in 2019, the Institute for Clinical and Economic Review (ICER) reported that the clinical evidence was still insufficient. A 2019 systematic review and meta-analysis of twelve clinical trials consisting of 1,041 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."

Medical uses

History

Society and culture

Legal status

Controversy

References

Further reading