First peanut allergy treatment nears FDA approval

The drug Palforzia is designed to minimize the incidence and severity of allergic reactions in people aged 4 to 17 who are allergic to peanuts.

While the advisory committee voted in favor of the treatment, the FDA will issue final approval by January. The agency frequently follows the example of the advisory committee. If approved, it will become the first FDA-approved treatment for peanut allergy.

“We are very pleased that the FDA’s Allergen Product Advisory Committee voted in favor of Palforzia,” said Jayson Dallas, CEO of drugmaker Aimmune Therapeutics. This recommendation recognizes the urgent need for patients to have a treatment option for their life-threatening allergy.”

Over 3 million Americans are allergic to peanuts and tree nuts. The American College of Allergy, Asthma and Immunology says 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 children with peanut allergies are exposed to peanuts, they may experience a range of symptoms, including cramps, indigestion, diarrhea, shortness of breath, tightness of breath, hives and swelling.

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

Current advice for allergy sufferers is to avoid peanuts. If exposed, people with allergies should use a drug like injectable epinephrine, commonly sold as the EpiPen, or for milder reactions, antihistamines.

Palforzia basically works by exposing children to controlled doses of peanut protein until they have reached a maintenance level. The company says in documents filed ahead of Friday’s meeting with the advisory committee that the treatment is a powder mixed once daily with certain foods like applesauce, yogurt and pudding.

A phase 3 trial presented as evidence in favor of the drug by the manufacturers found that 2/3 of children were able to eat the equivalent of 2 peanuts without any allergic symptoms after treatment. Patients may be required to follow the treatment for six months or more.

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

According to Aimmune Therapeutics, the advisory committee voted 7 to 2 in favor of the drug’s efficacy and 8 to 1 in favor of its safety for use in children as long as there were additional safeguards such as patients having a dose of injectable epinephrine. at hand.

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