Peanut allergy drug gets the tick in America

The US Food and Drug Administration has approved the first treatment for peanut allergy.

Children who take the new therapy are still advised to continue to avoid peanuts and to have access to emergency epinephrine shots. Picture: Thinkstock.

The US Food and Drug Administration has 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, is designed to work by exposing patients to the very substance they had been taught to avoid. The drug is derived from peanut powder.

To build up their resistance, children ages four to 17 who are prescribed the new therapy start with escalating doses of Palforzia mixed with apple sauce or other food every day.

Aimmune said the list price for Palforzia would be $US890 ($1330) a month. Roth Capital Research analyst Zegbeh Jallah estimates the drug could generate annual sales of $US1bn 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.

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 the drug was “intended to desensitise 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 Subhadra Siegel, chief of paediatric allergy and immunology at New York Medical College in Valhalla.

“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’ proposed new skin patch. Regeneron Pharmaceuticals also is developing an experimental peanut allergy drug.

Peanuts are among the most common foods that trigger allergies. Australia has a relatively high prevalence of peanut ­allergy. Almost three in every 100 children have a peanut ­allergy. About 20 per cent of children grow out of their allergy.

A 2017 US study estimated peanut-allergy prevalence had increased 21 per cent since 2010.

In people who are allergic, peanuts can cause gastrointestinal problems and anaphylactic shock. The standard way to manage the condition is to avoid ­exposure by scrutinising 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.

The clinical trial found that about 67 per cent 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 per cent of children who received a placebo.

About 14 per cent of Palforzia users had allergic reactions during the treatment period, versus 3 per cent of those on placebos.

The Wall Street Journal