On Friday, an expert advisory panel with the Food and Drug Administration (FDA) voted for the approval of a new treatment option for children with peanut allergies. The treatment, called Palforzia and produced by Aimmune Therapeutics, would be the first drug approved to prevent, or at least mitigate, life-threatening peanut allergies in children. The treatment is an oral immunotherapy and works by desensitizing people to their particular food allergy. It’s not considered a cure, but the medication could substantially reduce the risk of having a severe or life-threatening reaction. Though the FDA won’t make its final decision about Palforzia until early next year, it provides hope for that millions of children and teenagers who suffer from severe peanut allergies. “Successful oral immunotherapy can be a truly life-changing experience for not just the food-allergic individuals but also their families. It is very exciting to be on the cusp of FDA approval for the first therapeutic in food allergy. This is a great first step forward for our food allergy families,” Dr. Kari Nadeau, an allergist and the director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford, told Healthline. Peanut allergies are among the most common food allergy Peanut allergies are one of the most common food allergies in the United States, affecting more than 1.2 million children. When exposed to peanuts, children who are allergic may experience a range of symptoms, including vomiting, stomach cramps, indigestion, and diarrhea. The most severe reaction is known as anaphylaxis — this causes a whole-body reaction and includes impaired breathing, swelling in the throat, a drop in blood pressure, and fainting. Most allergic reactions can be treated with epinephrine — which is delivered through an EpiPen or other auto-injector. About 12 to 14 percent of peanut allergic children will have to go to the emergency room every year to treat their reactions, according to Dr. Sharon Chinthrajah, an allergist and immunologist with Stanford Healthcare. Avoiding food allergens has been the only way to prevent reactions. Palforzia could desensitize people to peanut allergens, potentially reducing the severity of their reaction. Some physicians recommend similar desensitization strategies exposing patients to traces of peanuts, though none require a prescription or insurance approval, according to Dr. Omid Mehdizadeh, an otolaryngologist and laryngologist at Providence Saint John’s Health Center. “Patients who have food allergies are looking for some therapy to mitigate this risk and improve the odds of [avoiding] a reaction from an accidental ingestion. This could have significant improvement in their quality of life since food is such a part of our social culture,” Chinthrajah said. Here’s how it works The new treatment involves taking daily capsules that contain small amounts of peanut flour. It starts with a very small amount of peanut protein, which is then slowly increased to 300 milligrams per day. The idea is to help children build up a tolerance to peanut allergens. After about 6 months, most children will be desensitized to small amounts of peanut protein and should be able to safely consume a small amount. “The treatment can turn a potentially life-threatening reaction to one that is more easily managed. By exposing the patient to controlled doses under supervision, accidental exposures may be less critical,” said Mehdizadeh. People with peanut allergies still wouldn’t be able to eat peanuts, but in the event they accidentally had a couple bites of something with bits of peanuts, their reaction would be much less severe. The medication would provide children with peace of mind that a tiny slip up wouldn’t necessarily land them in the emergency room. “Most food allergic patients are not looking to be able to eat the food. Instead, most want to be protected against accidental ingestions,” says Dr. Tina Sindher, an allergist and immunologist with Stanford Health Care. Some people may experience reactions The treatment does not come without risks. In the clinical studies evaluating the safety and efficacy of the therapy, some children experienced severe allergic reactions to the peanut powder. A handful stopped the treatment because the side effects were so severe. Others experienced coughing, hives, itching, throat irritation, nausea, and vomiting. But most, two-thirds, were able to tolerate about 600 milligrams of peanut protein after taking the pills, showing that the pill can be very effective in some people. The therapy is not considered to be a cure for most, says Nadeau. Additionally, researchers still aren’t sure what the optimal dose is, as it’s likely different for each individual, she added. Given the mix of side effects and risks, many health experts agree that more research is needed to better understand safety and efficacy of the drug. If the drug were to be approved, the FDA would permit it under specific requirements. First, all children carry epinephrine with them in the event a reaction does occur. Additionally, the first doses and increased doses would be need to be administered in a healthcare facility equip to treat allergic reactions. Even so, we are one big step closer to having an approved, effective treatment option for children with life-threatening peanut allergies. “This could have significant improvement in their quality of life since food is such a part of our social culture,” Chinthrajah said. The bottom line On Friday, an expert advisory panel with the FDA voted for the approval of a new treatment option for children with peanut allergies. The treatment would be the first drug approved to prevent, or at least mitigate, life-threatening peanut allergies in children. Many health experts agree that more research is needed to better understand safety and efficacy of the drug, but we’re a step closer to having an effective treatment option for children with severe peanut allergies. Source
