The Grapevine

FDA OKs First Ever Peanut Allergy Drug

A drug that could prevent the effects of peanut allergies may soon be available in the market. The U.S. Food and Drug Administration (FDA) has issued its recommendation for the first ever treatment for the condition. 

The decision comes after the agency’s Allergenic Products Advisory Committee meeting on Friday. FDA officials voted in favor of approving the peanut allergy drug, which will be marketed as Palforzia.

The drug promises to reduce the prevalence and severity of allergic reactions in people ages four to 17. There are more than three million people who are allergic to peanuts in the U.S., including more than 2.5 percent of American children, according to the American College of Allergy, Asthma and Immunology 

The FDA is expected to release its final approval to commercialize Palforzia in January, CNN reported Saturday. Experts have expressed confidence that the first peanut allergy drug will be available since the agency is known for frequently following the decision of its allergenic products committee. 

“We are very pleased that the FDA Allergenic Products Advisory Committee has voted in support of Palforzia,” Jayson Dallas, CEO of drug manufacturer Aimmune Therapeutics, said. “This recommendation recognizes the urgent need for patients to have a treatment option for their potentially life-threatening allergy.”

The committee voted seven to two for the effectiveness of Palforzia and eight to one to approve its safety.

Peanut Allergy in U.S.

This condition is known as one of the most common food allergies among children in the country. Peanut allergy could cause cramping, indigestion, diarrhea, shortness of breath, tightness of breath, hives and swelling.

Children are also at risk of anaphylaxis, a severe allergic reaction that triggers sudden drop in blood pressure, impaired breathing, fainting and dizziness. Anaphylaxis could also lead to death. 

Palforzia is designed to prevent such condition. The drug gives children controlled dosages of peanut protein.

It comes in a powder form that can be mixed with specific foods such as apple sauce, yogurt and pudding. During clinical trials, manufacturers said 2/3 of children who received Palforzia each day were able to eat two peanuts without any allergic symptoms.

“This is one of the most important unmet needs of medicine,” James Baker Jr., director of the Mary H. Weiser Food Allergy Center at the University of Michigan, said during the meeting with the advisory committee, as quoted by the New York Times. “Right now the only approved approach to this allergy is to avoid peanuts, and the amount of effort and cost involved in making sure everything your child is exposed to is peanut-free is overwhelming to most families.” 

Peanut The Food Allergy Research & Education estimates there is one person being rushed to the emergency room every three minutes in the U.S. due to a food allergy reaction. Pixabay