The U.S. Food and Drug Administration on Friday approved the first treatment for peanut allergy, providing a new option for the growing number of children and their families dealing with the life-threatening condition.
The new treatment, named Palforzia from Aimmune Therapeutics Inc., is designed to work by exposing patients to the very substance they had been taught to avoid. The drug is derived from peanut powder, and doses contain the equivalent of small amounts of peanuts.
To build up their resistance, children ages 4 to 17 years who are prescribed the new therapy start with escalating doses of Palforzia mixed with apple sauce or other food each day, and after reaching a certain dose continue on that dose indefinitely.
Aimmune said the list price for Palforzia will be $890 a month, or about $10,680 a year. Roth Capital Research analyst Zegbeh Jallah estimates the drug could generate annual sales of $1 billion by 2026.
A study showed the treatment increased the amount of peanuts that children could tolerate during a controlled “challenge” without having an allergic reaction, though it didn’t directly demonstrate whether the therapy protects against accidental encounters with peanuts.
Aimmune says the treatment isn’t intended to allow allergy patients to begin eating peanut-butter sandwiches, but rather to reduce the risk of reactions after accidental exposures.
Daniel Adelman, Aimmune’s chief medical officer, said on a conference call the drug is “intended to desensitize patients to peanut protein. So while they still must practice avoidance, it can mitigate allergic reactions after accidental consumption.”
Palforzia itself increased the risk of allergic reactions and use of emergency epinephrine shots during the 12 months of treatment preceding the food challenge.
Children who take the new therapy are still advised to continue to avoid peanuts and to have access to emergency epinephrine shots, such as EpiPen, in case of reactions.
Still, some doctors and patients say the drug will help reduce families’ anxiety about the risk of exposure in everyday life.
“It’s a big deal,” said Dr. Subhadra Siegel, chief of pediatric allergy and immunology at New York Medical College in Valhalla, N.Y. “The thought of relieving that anxiety and being able to eat in a restaurant without worry. These are huge debilitating things for families with food allergies.”
A second new treatment could become available later this year if the FDA approves DBV Technologies SA’s proposed new skin patch. Regeneron Pharmaceuticals Inc. also is developing an experimental peanut allergy drug.
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Peanuts are among the most common foods that trigger allergies. A 2017 study estimated peanut-allergy prevalence had increased 21% since 2010, and that it affected nearly 2.5% of American children.
In people who are allergic, peanuts can cause gastrointestinal problems and anaphylactic shock, a potentially deadly reaction that should be treated with an emergency epinephrine injection.
The standard way to manage the condition is to avoid exposure by scrutinizing food ingredients, and to have access to epinephrine for emergencies.
Some allergists have treated peanut allergies by giving children small amounts of peanut flour, but until now there hadn’t been an FDA-approved treatment.
The Aimmune treatment builds on the exposure approach by placing doses of peanut powder in capsules, which are broken open to sprinkle on food.
Aimmune says its doses are precisely measured to ensure a more consistent amount of the allergy-causing component of peanuts than if families or doctors try to give children small amounts of peanut flour or kernels. Patients start with a small dose and escalate it gradually over six months. Thereafter, they stay on a maintenance dose that is equivalent to about one peanut kernel a day.
In clinical testing of the drug, children with peanut allergies were studied to see how much peanut flour they could tolerate before having an allergic reaction, to set a baseline. The so-called peanut challenge was conducted in medical facilities, with epinephrine on hand.
After taking Palforzia or placebo for one year, the study subjects underwent another peanut challenge in which they were given escalating amounts of either placebo or peanut flour.
Noah Townsend of Orlando, Fla., enrolled in a clinical trial for Palforzia in 2016, when he was 10 years old and accustomed to avoiding peanuts most of his life. He had an allergic reaction to peanut butter when he was about 18 months old.
“Just imagine your parents had always told you, ‘This was poison. This will kill you.’ And now we’re saying, ‘Eat it,’” said Noah’s mother, Wendy Cramer Townsend.
At the start of the study, the equivalent of one-third of a peanut kernel triggered an allergic reaction in Noah. After 12 months of treatment, he was able to take the equivalent of about 14 peanuts without having a reaction, Ms. Cramer Townsend said.
He continues to take Palforzia, which has given him more independence and his parents more peace of mind. “He’ll never have a peanut butter sandwich but if he goes out with friends to some Chinese restaurant and accidentally gets a peanut, he’s OK,” Ms. Townsend said.
The clinical trial found that about 67% of children who took Palforzia were able to ingest the equivalent of at least two peanut kernels without having significant allergic symptoms, compared with 4% of children who received a placebo. Palforzia also limited the severity of symptoms compared with placebo.
About 14% of Palforzia users had systemic allergic reactions during the treatment period, versus 3% of those in the placebo group.
The increased risk of reactions raised concerns among some allergists. “Patients undergoing this treatment end up needing epinephrine twice as often as the patients who are not undergoing treatment,” Dr. John Kelso, an allergist with Scripps Health in San Diego, said at a September 2018 meeting of an FDA advisory committee considering Aimmune’s proposed treatment. “So it is not clear to me that this treatment is effective.”
Another FDA committee member, Ira Finegold, a professor of clinical immunology at the Icahn School of Medicine at Mount Sinai in New York City, voted in favor of Palforzia because, he said, “even though this isn’t perfect, and it’s obviously not for everybody, it’ll go a long way in helping patients and their quality of life.”
Steve Tilles, Aimmune’s senior medical director, said the adverse events associated with Palforzia dissipated as treatment continued.
Write to Peter Loftus at peter.loftus@wsj.com
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