The first food allergy treatment in the world! Aimmune oral immunotherapy palforzia is approved by the United States to treat peanut allergy, with an annual sales volume of $1.75 billion!

February 5, 2020 / BIOON / -- aimmune therapeutics is a biopharmaceutical company focusing on developing innovative therapies to treat potentially life-threatening food allergies Recently, the company announced that the U.S Food and Drug Administration (FDA) has approved peanut allergy immunotherapy palforzia (peanut allergen powder dnfp, development code: ar101) It is worth mentioning that palforzia is the world's first approved treatment for peanut allergy, and also the world's first approved treatment for any food allergy Previously, FDA has granted the fast track qualification and breakthrough drug qualification for peanut allergy treatment Peanut allergy is one of the most common food allergies in the world In the United States alone, more than 1.6 million children and adolescents are allergic to peanut For a long time, the standard care for children and adolescents with peanut allergy has been strict peanut elimination diet, as well as timely administration of rescue drugs in case of allergic reactions caused by accidental intake of peanut Despite a high level of vigilance, accidental ingestion of peanuts can occur, leading to unpredictable allergic reactions of varying severity and a lifetime risk of serious allergic reactions Palforzia is an oral immunotherapy (OIT) for patients with peanut allergy, which can reduce the possible allergic reactions, including severe allergic reactions, after accidental intake of peanut Palforzia can be initiated and maintained in 4-17-year-old children and adolescents, and should be continued at the age of 18 unless otherwise directed by the doctor Palforzia will be used in combination with the peanut avoidant diet, which means that patients taking the drug should avoid peanuts in their diet It should be noted that the drug is not suitable for the emergency treatment of peanut allergy (including severe allergic reaction), and should not be taken during peanut allergy Peanut allergy is a $3 billion market As the first drug to treat peanut allergy, the industry is very optimistic about the business prospects of palforzia Evaluatepharma, a pharmaceutical market research firm, had previously predicted that palforzia's sales would reach $1.75 billion in 2024 Palforzia is the first product developed with the proprietary oral desensitization immunotherapy (codit) treatment platform of aimmune company, which aims to desensitize patients with a clear and accurate number of key allergens, so as to provide a meaningful level of protection against the immune response caused by accidental ingestion of food allergens Palforzia is composed of key allergens extracted from peanuts It is a powder with fixed ingredients, packed in color coded capsules (for dose increase and dosing) and small bags (300mg / bag, for maintenance treatment) When taking medicine, take the powder out of the capsule or small bag, mix it with a small amount of semi-solid food (such as applesauce, yoghurt or pudding), and then eat it Palforzia treatment can be divided into three stages: single day dose increasing stage, dosing stage and maintenance treatment stage See the following table for details of each stage of drug use: the efficacy and safety data of 7 clinical studies were included in palforzia's biological product licensing application (BLA), including 2 key phase III clinical trials of palisade and Ramses, phase II arc001 and arc002 open label follow-up studies, and the data of arc004, arc008 and arc011 in progress Palforzia's effectiveness was supported by a randomized, double-blind, placebo-controlled clinical trial in the United States, Canada, and Europe involving about 500 individuals with peanut allergy The efficacy was assessed by assessing the percentage of subjects who were resistant to oral challenge with a single dose of 600 mg peanut protein (twice the daily maintenance dose of palforzia) and no more than mild allergic symptoms after 6 months of maintenance treatment The results showed that 67.2% of the subjects in the palforzia group tolerated 600 mg of peanut protein in the oral challenge, while only 4.0% in the placebo group Palforzia's safety was evaluated in two double-blind, placebo-controlled clinical studies involving about 700 individuals with peanut allergy In the study, the most common side effects of palforzia were abdominal pain, vomiting, nausea, tingling in the mouth, pruritus (including the mouth and ears), cough, runny nose, throat discomfort and tightness, urticaria, wheezing, shortness of breath, and allergic reactions Palforzia should not be used in individuals with uncontrolled asthma Original source: FDA approvals aimmune's palforzia Gamma as First Treatment for Peanut Allergy