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FDA Approves Children’s Peanut Allergy Drug

Palforzia capsules

Palforzia capsules (Aimmune Therapeutics Inc.)

3 Feb. 2020. The U.S. Food and Drug Administration on Friday approved the first treatment for children to reduce severe allergic reactions to peanuts. The biologic therapy Palforzia, made by Aimmune Therapeutics Inc. in Brisbane, California, is designated for children age 4 to 17, but only as part of a monitored risk-reduction strategy.

Allergies to peanuts and other foods are a result of the body’s immune system misinterpreting certain foods as pathogens, and responding by the release of histamines, chemicals in the body causing the allergy symptoms. In most cases, the symptoms are mild, such as runny nose and itching, but people with peanut allergies face a real and elevated risk of anaphylaxis, a life-threatening condition constricting airways, swelling the throat, and causing a sharp drop in blood pressure. The company cites data from National Institute of Allergy and Infectious Diseases, and others, showing more than 30 million people in the U.S. and Europe live with food allergies.

Palforzia is designed to desensitize people with food allergies to allergens, proteins in food causing allergic reactions. The company’s technology known as Codit exposes people with food allergies to increasing amounts of allergens over six months, thereby desensitizing the individuals to the allergen. Codit, says Aimmune, enhances conventional oral immunotherapies by precisely controlling the amount of offending food protein ingested by people with food allergies and establishing treatment routines that start with very small amounts and gradually increasing the amounts over time.

Treatments with Palforzia start with a very small dose of peanut protein, followed by 11 increasing dose levels over several months. Both the initial dose and at least the early stages of increasing Palforzia quantities are given under the supervision of clinicians in a health care setting, to monitor for reactions including anaphylaxis. Later stages of increasing Palforzia doses may be given at home, as well as daily maintenance doses after a safe final quantity is reached. The treatments are packaged in color-coded capsules containing precise doses of peanut powder, for mixing in semi-soft foods like pudding or applesauce.

Aimmune says its FDA application was supported by seven clinical trials, but the agency cites a late-stage trial showing the effectiveness of Palforzia, code-named AR101 at the time. As reported by Science & Enterprise in November 2018, the primary outcome of the trial in North America was the ability to ingest 600 milligrams of peanut protein, with no more than mild reaction symptoms, after the 12-month period.

About two-thirds (67%) of all children receiving AR101 were able to tolerate 600 milligrams of protein, compared to four percent of placebo recipients. But trials of AR101 also show a high risk of allergic reactions, including anaphylaxis, thus FDA’s requirement that Palforzia be given only as part of a clinician-directed risk evaluation and mitigation strategy.

Daniel Adelman, Aimmune Therapeutics’ chief medical officer cites a key role played by peanut allergy organizations and families in developing Palforzia. In a company statement, Adelman credits, “more than 1,200 patients and their families who participated in our clinical trials, the study investigators and their staff, the advocacy community, and our dedicated employees, all of whom have helped us develop and deliver this first-of-its kind therapy.”

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