The FDA takes a big step forward in approving the first peanut allergy treatment



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The FDA takes a big step forward in approving the first peanut allergy treatment

Copyright 2019 CNN

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WASHINGTON, D.C. – The US Food and Drug Administration's Allergen Advisory Committee voted Friday in favor of treatment for peanut allergies in children.

Palforzia is designed to minimize the incidence and severity of allergic reactions in peanut-allergic people aged 4 to 17 years.

While the advisory committee voted in favor of treatment, the FDA will give final approval in January. The agency often follows the leadership of the advisory committee. If approved, it will become the first FDA approved peanut allergy treatment.

"We are delighted that the FDA Advisory Committee on Allergens has voted in favor of Palforzia," said Jayson Dallas, CEO of drug manufacturer Aimmune Therapeutics. This recommendation recognizes the urgent need for patients to have a treatment option for their life-threatening allergy. "

More than 3 million Americans are allergic to peanuts and nuts. The American College of Allergy, Asthma and Immunology indicates that more than 2.5% of American children are allergic to peanuts.

Peanut allergy is one of the most common food allergies in American children. If peanut-allergic children are exposed to it, they may have a range of symptoms, including cramps, indigestion, diarrhea, shortness of breath, shortness of breath, hives, and swelling.

The most serious reaction is anaphylaxis, when the whole body reacts with symptoms such as impaired breathing, a sudden drop in blood pressure, fainting and dizziness. Anaphylaxis can be fatal if it is not treated immediately.

The current advice for allergy sufferers is to avoid peanuts. In case of exposure, allergy sufferers should use a drug such as epinephrine injection, usually sold under the name EpiPen, or, for less severe reactions, antihistamines.

Palforzia works by exposing children to controlled doses of peanut protein until they reach a maintenance level. The company says in documents tabled before the Friday meeting with the advisory committee that the treatment consists of a powder mixed once a day with certain foods such as applesauce, yogurt and pudding.

A phase 3 trial presented as evidence in favor of the drug by manufacturers showed that two-thirds of children were able to eat the equivalent of two peanuts without any allergic symptoms after treatment. Patients may be required to take treatment for six months or longer.

The company said the most common side effects were: abdominal pain or discomfort, cough, hives, itching, nausea, throat irritation and vomiting. However, approximately 9% of children treated with Palforzia during the trial had to stop treatment because of the severity of their allergic reactions.

According to Aimmune Therapeutics, the advisory committee has voted in favor of 7 to 2 for the effectiveness of the drug and 8 to 1 for its safety in the use of it in children, provided that it is safe to use. there are additional safeguards, such as patients receiving a dose of injectable epinephrine. at hand.

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