- 2019 may be the year of the first treatments for children with peanut allergies.
- Two companies are competing for a market of around $ 3 billion. Both are seeking approval from US. It. Regulators to start selling their products.
- These treatments are not cure, but the risk of a dangerous allergic reaction to peanuts.
- Some parents say they prefer one product over the other, but it has a key drawback.
Josh Mandelbaum, 13, has a secret.
For five years, a small round sticker on his back, around the size of 1/4, contained the very thing that the New Jersey teen is allergic to: Peanuts.
The patch is part of a growing pace that aims to use triggers like peanuts to help those with allergies. The purpose is to disinfect them and act as a kind of garbage rail against accidental exposure.
You may soon be able to get a prescription for these treatments. The patch and another first-of-its-type peanut allergy pill can be approved by US. It. Regulators as early as next year, and both have the potential to be blockbuster medications.
About 15 million people in the US. It. Have food allergies to things like milk, eggs and wheat. Peanut allergies are the most common food allergy among children, and have been on the rise over the last decade. The market for the treatments is huge, and eventually could reach around $ 3 billion in total sales, according to Stellar Analyst Derek Archilla.
Doctors have little to offer patients, while they recommend avoiding allergies and always accept an ampon or product to save them if they have a life-threatening allergic reaction. Moreover, those with peanut allergies are less likely to outbreak it than other food allergies, and it's hard to predict how severe an allergic reaction may be.
A treatment, not a cure
The new approach was worked for Josh, his mother, Lianne Mandelbaum, who is also a Food Allergy Attorney, told Business Insider. Josh first tried this product, Dvaskin Peanut DWW Technologies, as part of a clinical trial years ago.
In the beginning, as part of a "food challenge" used in the process, Josh has an allergic reaction after eating the equivalent of a fraction of a peanut, Lianne Mandelbaum said. Two-and-a-half years later, it took a lot more about one and a half peanuts to spur a reaction.
While that may sound like a tiny change, it's a huge difference in how life's life is going on. He can now confidently go to school and sit in a cafeteria that serve peanut butter, for example, his mother said.
The patch is not a cure: Josh continues to avoid peanut products, for example, and should be careful about the acceptance of foods that may be unsafe. But it was empowering, she said, and gave them peace of mind.
"I just do not want him to die from eating the wrong cookies," she said. "We live in a human society. People make mistakes. So what you want a safety gap."
Mandelbaum was so happy with the results that she fought to let Josh keep using the patch after the trial ended, through an expanded access program. The only side effects he's seen are Jichi Red Worth, which have eased over time.
Josh would wear it for the rest of his life if he did, she told Business Insider.
As it all came together
People with allergies are usually advised to keep away from what they are allergic to.
But controlled exposure, called immunotherapy, was also part of the arsenal of arsenal of tools for many years now, including allergies to dust, mold, dust and more.
Doctors in private practice have also tried this with peanuts and other food allergies. In what is called "oral immunotherapy treatment," patients eat small amounts of peanut or other allergens, which increases over time.
Although they have success, they are not approved by the US. It. Food and Drug Administration and can not be covered by health insurance. And, as other immunotherapy approaches, they have a risk, including the chance of an allergic reaction.
The search for a more standardized approach eventually led to the creation of Aimune, which is developing AR 101, a capsule of peanut protein that is mixed in food.
When the company was first started, the big question was "How do you take a food, which is inherently variable and highly unpredictable, and make it in a drug?" DC Daniel Adelman, the chief medical officer of Aimune, explained.
The company has done that by focusing on peanut protein, which is where the allergens in the nut are, and using that to re-emit the immune system, he said.
Search for FDA
The dosage of R. 101 starts at a very low level, or helps a milliameter of peanut protein, and then increases over six months to 300 milligrams or approximately the equivalent of one peanut kernel. Patients then continue on that level as a maintenance dose.
AIMMUNE aims to file with the FDA this month for approval to treat patients 4-17; A decision may arrive early in 2019. DBF filed for FDA approval from Viaskin Peanut in October to treat patients ages 4-11, with a decision to be held next year.
These products can potentially reduce a life-threatening allergic reaction to a mild one, give patients, their loved ones and their doctors an added layer of safety, DR. Purwy Parich, Clinical Assistant Professor at NYU Langone and a board-certified allergist, told Business Insider.
If they are found to be safe and effective, they may dramatically change patients' quality of life, Parikh has, reducing an untold amount of anxiety and stress for them and their families.
But which company can end up leading the site is more unclear. A group of doctors blocked by Stell's Archilla a little favored DBN's product, he said, though the analyst also noted that there was a controversy over DWW's clinical trial data.
Some parents of children with allergies told Business Insider that dub's patch was safe to them because it does not really need to eat an allergy. The company also notes this as a potential benefit on its website, saying that its approach "offers a potentially strong safety profile because of how it works through the skin."
Read more: An experimental treatment for peanut allergies only succeeded in a key process
Tamara Hubbard, a licensed counselor in which nine years old son participated in an ongoing process for the patch, called the "Life-Changing" product. She was primarily drawn to it over other options because the trial was slower and avoided by gastrointestinal side effects, Hbbard said.
A giant question mark
On the other hand, those on the patch would probably not know just how much allergies they can tolerate, because they do not end up eating a "food challenge," they would not eat.
What product a family chooses will likely depend on their own preferences, Hubbard, which specializes in Food Allergy Counseling, among other things, said.
Aimune's Adelman also emphasized the recent perspective in an interview with Business Insider.
"I think that the greatest danger to a kid who is Peanut Allergic is coming out in the world and thinking they are protected if they're gone," he said.
Pricing – Another big question mark hovering overhead – may also be an important factor. The Institute for Clinical and Economic Review, a nonprofit that evaluates drug prices, is still reviewing the products and plans to deliver reports on them in the first half of next year.
The companies have not said how much these drugs will cost.
Parents, meanwhile, said they hope everyone wants the products they can get.
"Everybody who has food allergies deserves to have access to living treatment," said Fleischer's allergy lawyer Mandelbaum. "It should be available to everyone."