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- 2019 could be the year of the first treatments for children allergic to peanuts.
- Two companies are fighting for a market of about $ 3 billion. Both seek US regulatory approval to start selling their products.
- The treatments are not a cure, but they reduce the risk of a dangerous allergic reaction to peanuts.
- Some parents say they prefer one product over another, but this one has a major disadvantage.
Josh Mandelbaum, 13, has a secret.
For five years, a small circular sticker on his back, about the size of a quarter, contains the very substance that the New Jersey alliance is allergic to: peanuts.
The patch is part of a growing trend that aims to use triggers like peanuts to help people with allergies. The goal is to desensitize them and act as a kind of guardrail against accidental exposures.
You may soon be able to get a prescription for these treatments. The patch and another peanut allergy pill, a first of its kind, could be approved by US regulators next year, and both could become star drugs.
In the United States, about 15 million people have food allergies to milk, eggs and wheat. Peanut allergies are the most common food allergy in children and have increased over the last decade. The treatment market is huge and could eventually reach a total business figure of about $ 3 billion, according to Stifel analyst, Derek Archila.
At the present time, doctors have little to offer patients, apart from advising them to avoid allergy problems and always wear an EpiPen or similar product to save them. if they have an allergic reaction putting their life in danger. In addition, people allergic to peanuts are less likely to become allergic to other food allergies and it is difficult to predict the severity of an allergic reaction.
A cure, not a cure
The new approach worked for Josh, his mother, Lianne Mandelbaum, who is also a food allergy advocate, told Business Insider. Josh first tested the product, Viaskin Peanut from DBV Technologies, as part of a clinical trial several years ago.
At first, as part of a "food challenge" used in the test, Josh had an allergic reaction after eating the equivalent of a peanut fraction, said Lianne Mandelbaum. Two and a half years later, it took a lot more, about half a peanut, to provoke a reaction.
While this may seem like a minimal change, it has made a huge difference in how Josh leads his life. He can now go to school with confidence and sit in a cafeteria serving peanut butter, for example, said his mother.
The patch is not a cure: Josh continues to avoid peanut products, for example, and must be careful not to accept foods that could be dangerous. But it was stimulating, she said, and gave them peace of mind.
"I just do not want him to die from eating bad cookies," she said. "We live in a human society, humans make mistakes, that's why you want a security gap."
Mandelbaum was so pleased with the results that she fought to allow Josh to continue using the patch after the trial ended, through an extensive access program. The only side effects observed are itchy redness that has diminished over time.
Josh would wear it all his life if he had to, she told Business Insider.
How everything came together
It is generally advisable for people with allergies to avoid what they are allergic to.
But controlled exposure, called immunotherapy, has also been part of the arsenal of allergist tools for many years, including using allergy vaccines for pollen, mold, dust, etc.
Physicians in private practice have also tried this with peanuts and other food allergies. In what is called an "oral immunotherapy treatment", patients eat small amounts of peanuts or another allergen, which increases with time.
Although these have been successful, they are not approved by the US Food and Drug Administration and may not be covered by health insurance. And, like other approaches in immunotherapy, they carry risks, including the risk of allergic reaction.
The search for a more standardized approach eventually led to the creation of Aimmune, which is developing AR101, a peanut protein capsule that is mixed with food.
When the company was created, the big question was "how to take an inherently variable and highly unpredictable food to make it a medicine?" Dr. Daniel Adelman, Chief Medical Officer of Aimmune, explained.
The company did this by focusing on peanut protein, where the allergens are, and using it to re-educate the immune system, he said.
Seeking FDA approval
The dose of AR101 starts at a very low level, half a milligram of peanut protein, and then increases for about six months to 300 milligrams, roughly equivalent to the same amount. a peanut kernel. Patients then continue at this level as a maintenance dose.
Aimmune wishes to submit to the FDA this month a request for authorization for the treatment of patients aged 4 to 17 years. a decision could arrive early in the fall of 2019. In October, DBV filed an application for Viaskin Peanut's approval with the FDA for the treatment of patients aged 4 to 11 years. A decision should be made next year.
The products could potentially reduce a life-threatening allergic reaction of a less severe person, giving patients, their loved ones and their doctor an extra layer of safety, explained Dr. Purvi Parikh, assistant professor Clinic at NYU Langone and Certified Internal Allergist from the business community.
If they are found to be safe and effective, they could dramatically change the quality of life of patients, said Parikh, thereby reducing the anxiety and stress they were experiencing, as well as those of their families.
But which company could end up directing the space is more blurred. A group of doctors interviewed by Archila of Stifel was slightly in favor of DBV's product, he said, although the analyst also noted the controversy surrounding DBV clinical trial data.
Some parents of allergic children told Business Insider that the DBV patch seemed safer, as it did not actually require eating an allergen. The company also has this potential advantage on its website, claiming that its approach "offers a potentially high safety profile due to its skin-based operation."
Read more: Experimental treatment for peanut allergies just passed a key test
Tamara Hubbard, a licensed counselor whose nine-year-old son is taking part in an ongoing patch trial, described the product as a "life-changing". She was initially attracted to other options because the process was slower and avoided the gastrointestinal side effects, Hubbard said.
A giant question mark
On the other hand, people on the patch will probably not know exactly how much allergen they can tolerate, because if they did not meet a "food challenge", they would not eat it.
The product chosen by a family will therefore likely depend on their own preferences, said Hubbard, a food allergy consultant, among others.
Adelman of Aimmune also pointed this last perspective in an interview with Business Insider.
"I think the biggest danger for a child allergic to peanuts is to go out into the world and think that it's protected if it's not the case," he said. declared.
Pricing – another giant question mark hovering overhead – could also be an important factor. The Institute for Clinical and Economic Review, a non-profit organization that evaluates drug prices and is still studying the products and plans to publish reports on this topic in the first half of next year.
Companies have not specified the price of drugs.
The parents, meanwhile, said hope that all those who want these products can get them.
"All those with food allergies deserve access to life-saving treatments," said Mandelbaum, a food allergy lawyer. "It should be available to everyone."
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