- 2019 may be the year of the first treatments for children with peanut allergies.
- Two companies are competing for a market of about $ 3 billion. Both seek approval from US regulators to begin selling their products.
- 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 the other, but they have a key drawback.
Josh Mandelbaum, 13, has a secret.
For five years, a small circular sticker on the back, about a quarter, contained precisely what the teenager in New Jersey was allergic to: peanuts.
The virus is part of a growing trend that aims to use triggers like peanuts to help those with allergies. The goal is to desensitize and act as a kind of protective tire from accidental exposure.
You will soon be able to get a prescription for these treatments. The scalp and another pill for allergy to peanuts can be approved by U. S. regulators since next year, both have the potential to be blockbuster drugs.
About 15 million people in the United States have food allergies to things like milk, eggs and wheat. Peanut allergies are the most common food allergy in children and are on the increase over the last decade. The treatment market is huge and may eventually reach about $ 3 billion in total sales, according to Stiefel analyst Derek Archila.
Doctors currently have little to offer patients except to advise them to avoid allergies and always wear EpiPen or such a product to save them if they have a life-threatening allergic reaction. In addition, those with peanut allergies are less likely to overcome it than other food allergies, and it is difficult to predict how serious an allergic reaction might be.
Treatment, not a cure
The new approach worked for Josh, his mother, Liana Mandelbaum, who is also an advocate of food allergy, told Business Insider. Josh first tried the product, DVV Technology Viaskin Kikit, as part of a clinical trial several years ago.
Initially, as part of the "food challenge" used in the trial, Josh had an allergic reaction after eating the equivalent of some peanuts, said Liana Mandelbaum. Two and a half years later, it takes a lot more, about one and a half peanuts, to trigger a reaction.
Although it may sound like a little change, it's made a huge difference in how Josh lives his life. He can now safely go to school and sit in a cafe serving peanut butter, for example, his mother said.
The corpse is not a cure: Josh continues to avoid peanut products, for example, and must be careful in accepting food that can be unsafe. But that's strengthening, she said, and gave them peace of mind.
"I just do not want to die from eating the wrong cookies," she said. "We live in a human society, people make mistakes. Therefore, you want a security gap."
Mandelbaum was so pleased with the results he was struggling to allow Josh to continue using the sticker after the trial, through an extended access program. The only side effects he has seen are nervous red teeth, which have slowed down over time.
Josh will carry it to the end of her life if she has to, she told Business Insider.
How it all came together
People with allergies are usually advised to stay away from what they are allergic to.
But controlled exposure, also called immunotherapy, has also been part of an arsenal of allergy tools for many years, including through allergic shots for pollen, mold, dust, and more.
Doctors in private practice have also tried this with peanuts and other food allergies. In what is termed "oral immunotherapy", patients eat small amounts of peanuts or another allergen, which increases over time.
Although these have success, they are not approved by the US Food and Drug Administration and can not be covered by health insurance. And, like other approaches to immunotherapy, they have risks, including the possibility of an allergic reaction.
The demand for a more standardized approach eventually led to the creation of Aimmune, which develops AR101, a capsule of peanut protein that is mixed in food.
When the company was first opened, the big question was "how to get food, which is inherently variable and very unpredictable, and make it into a cure?" Explained Dr. Daniel Adelman, Chief Medical Officer of Aymun.
The company did it, focusing on peanut protein, where allergens are in the nut and use it to restore the immune system, he said.
Request FDA approval
The dosage of AR101 starts at a very low level, or half a milligram of peanut protein, and then increases by about six months to 300 milligrams, or roughly the equivalent of a peanut kernel. Patients then continue to this level as a maintenance dose.
Aimmune aims to submit to the FDA this month for approval for the treatment of patients aged 4 to 17; the decision could arrive by the beginning of autumn 2019. DVB filed a request for approval by the FDA of Viasquin Kikington in October for the treatment of patients aged 4 to 11, with a decision expected next year.
Products could potentially reduce the life-threatening allergic life-threatening reaction, giving patients, their loved ones and their doctors an additional layer of safety, Dr. Purvey Parich, a clinical assistant professor at NYU Langone and a board certified allergist. Business insider.
If found to be safe and effective, they could dramatically change the quality of life of patients, said Parich, reducing the incurable surprise and stress for them and their families.
But which company could end up with space management is still unclear. A group of doctors surveyed by Archile on Stiefel slightly favored the production of DBV, he said, although the analyst also noted that there was controversy over data from a clinical trial of DBV.
Some parents of children with allergies told Business Insider that the DBV porcelain seemed to them safer because it did not require to actually eat allergen. The company also highlights this as a potential benefit to its website, saying its approach "offers a potentially strong security profile because it works through the skin".
Read more: Experimental treatment of peanut allergies has just succeeded in a key examination
Tamara Hubbard, a licensed counselor whose nine-year-old son is taking part in an ongoing patch trial, called the product "life changing". She was initially attracted to her because of other options, as the process was slower and avoided gastrointestinal side effects, said Hubbard.
A gigantic questionnaire
On the other hand, those on the patch are unlikely to know exactly how many allergens can tolerate, because – the absence of completing the "food challenge" – they would not eat.
Which product the family chooses will most likely depend on its own preferences, Hubbard, who specializes in food allergy counseling, among other things.
Adelman of Aimmune also highlighted the last perspective in an interview with Business Insider.
"I think the biggest danger for a kid that is peanut allergic is going to the world and thinking that they are protected if they are not," he said.
Prices – another giant query overhead – can also be an important factor. The Institute for Clinical and Economic Review, a non-profit organization that evaluates drug prices, is still reviewing products and plans to publish reports on them in the first half of next year.
Companies did not say how much would cost the drug.
Parents, however, said they hope that anyone who wants these products to get them.
"Anyone who has food allergies deserves to have access to a rescue treatment," said food allergy advisor Mandelbaum. "It should be accessible to everyone".