First food allergy treatment! FDA approved palforzia for peanut allergy treatment

On January 31, the FDA approved palmforzia of aimmune therapeutics to reduce possible allergic reactions, including severe allergic reactions, in case of accidental contact with peanuts Children and adolescents between 4 and 17 years old diagnosed with peanut allergy can start to use palforzia treatment, and can continue to use palforzia treatment in individuals aged 4 and above Patients taking palforzia must continue to avoid peanuts in their diet Palforzia is the first FDA approved food allergy treatment Palforzia's principle is to gradually desensitize the immune system of peanut allergy patients by taking a small amount of peanut protein, so that when they accidentally contact peanut ingredients in the real world, they are less likely to have life-threatening allergic reactions Palforzia is a protein component extracted from peanut, which contains the main sensitizing protein, and the component is fixed Palforzia's effectiveness was supported by a randomized, double-blind, placebo-controlled clinical study of about 500 individuals with peanut allergy in the United States, Canada, and Europe Efficacy was assessed by assessing the percentage of subjects who did not show more than mild anaphylaxis symptoms after receiving a single oral dose of 600 mg of peanut protein (twice the daily maintenance dose of palforzia) after 6 months of maintenance treatment The results showed that 67.2% of palforzia recipients tolerated a challenging 600 mg dose of peanut protein, compared with 4.0% of placebo recipients; the safety of palforzia was evaluated in about 700 peanut allergy individuals in two double-blind, placebo-controlled clinical studies The most commonly reported side effects of palforzia are abdominal pain, vomiting, nausea, tingling in the mouth, pruritus (including the mouth and ears), cough, runny nose, throat irritation and tightness, urticaria, wheezing and shortness of breath, and allergic reactions People with uncontrolled asthma should not take palforzia Peanut allergy is a disease that the human immune system mistakenly recognizes even a small amount of peanut as harmful The occurrence and expression of allergic reactions to peanut are unpredictable, and some individuals may even have minor serious reactions Physical symptoms may occur within seconds of exposure and may include skin reactions (e.g., hives, redness or swelling), digestive system discomfort or more dangerous reactions such as throat and airway constriction, and loss of adequate blood flow to vital organs of the body Antihistamines and epinephrine can be used to treat allergic reactions, but severe reactions can be fatal even if they are properly and timely treated Palforzia cannot be used for emergency treatment of anaphylaxis, including anaphylaxis Peter marks, M.D., Ph.D., director of the FDA Center for biological product evaluation and research, said, "peanut allergy has affected about 1 million children and adolescents in the United States, and only one fifth of them are allergic to them Because there is no cure, people with allergies must strictly avoid contact to prevent serious and potentially life-threatening reactions Even if strictly avoided, accidental contact can occur Palforzia offers an FDA approved treatment option to help reduce the risk of these allergic reactions in children and adolescents with peanut allergies " Palforzia is a peanut powder packaged in separate color coded capsules for dose escalation and dosing, and in small bags for maintenance The powder is poured from the capsule or pouch and mixed with a small amount of semi-solid food (such as applesauce, yoghurt or pudding) for the patient to eat The treatment of palforzia consists of three stages: initial dose determination (incremental), administration and maintenance The initial dose increasing stage was completed in one day, and the adding stage included 11 dose increasing levels, lasting for several months The initial dose increase and each dose increase should be carried out under the supervision of health care professionals in a healthcare environment with the ability to deal with potentially serious allergic reactions (including allergic reactions) Although anaphylaxis may occur at any time during palforzia treatment, patients are at the highest risk during and after the initial dose increase and the first administration of each dose increase level During the dosing process, if the patient tolerates the first administration of the increased dose level, the patient can continue to give the dose level at home every day; after the patient completes all dose increases, he can start to maintain the dose every day Patients with certain allergic reactions due to palforzia may need to discontinue treatment or adjust the dosage regimen (BIOON Com)