Two emerging therapies received the Food and Drug Administration’s (FDA) “Breakthrough” designation for the treatment of food allergy this year. We’ll take a look at what it means to be a breakthrough therapy, who is developing these them, how they work, and the (big) business drivers behind them.
The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in July 9, 2012. Section 902 of the legislation provides for a new fast track designation – Breakthrough Therapy. According to the FDA, a breakthrough therapy is a drug:
- intended for use alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
- preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
A drug given such a designation is provided expedited review by the FDA, though the sponsor must still demonstrate that it is effective and safe. The FDA assigns senior resources to work with the sponsor on a continual basis to speed up the entire process from clinical trials through approval.
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By now you may have read of yet another food allergy-related tragedy, the passing of Simon Katz, a 16-year old student of Chatfield High School in Littleton, Colorado. He was rushed to the hospital on Monday after inadvertently taking a bite of a s’more made with peanut butter at a school homecoming celebration after suffering anaphylactic symptoms. He was pronounced dead at the hospital despite multiple shots of epinephrine and CPR administered by his father on the way.
This was the second report of a teen death due to anaphylaxis in a week, yet another horrific nightmare to befall a member of the allergic community. Our heartfelt and deepest sympathies are with the Katz family.
As we generally do when anaphylaxis-related tragedies appear in the news, we seek out the only good that can come from such reports, namely learning from the experience to prevent such occurrences in the future. Here are a number of extenuating circumstances that were reported in the media:
- Simon did not have his epinephrine auto-injectors on-hand
He had a habit of keeping his auto-injectors in his car, but he caught a ride to school that day with his friends. By the time his friends were able to transport him home, he was vomiting and suffering severe symptoms.
Early administration of epinephrine is paramount to the successful treatment of anaphylaxis and it should be administered as soon as symptoms present themselves, or immediately after inadvertently ingesting an allergen that has caused anaphylaxis in the past as directed by your physician. On the best day, Simon’s epinephrine was waiting in the parking lot and administration would have been delayed; on this, the worst day, his epinephrine was not available, possibly costing him his life.
- He was taken home instead of straight to the emergency department of the closest hospital
Simon was in the throes of a severe anaphylactic response to a known allergen, a medical emergency by any definition. While we sympathize with his friends who thought they were doing the right thing, they should have been educated to seek immediate medical attention for him.
- He consumed an unwrapped food that did not come from home
Simon’s father, David Katz, told reporters that s’mores were one of Simon’s favorite treats, but he mistakenly ate one that was made with Reese’s Peanut Butter Cups. It is presumed the peanut butter was the trigger of his allergic response.
Global News has provided additional details regarding the Andrea Mariano tragedy. The teen, who was enjoying her second day of campus life as a psychology student at Queen’s University in Ontario Friday, perished as a result of an anaphylactic reaction.
Ms Mariano, who was allergic to both dairy and peanuts, consumed a smoothie that was cross-contaminated with one of her allergens. It is unclear whether the smoothie came from a campus outlet or the university dining hall, and which allergen was the cause.
A student who had just begun her college studies at Queen’s University in Kingston, Ontario, died as a result of a severe allergic reaction, the school website reports.
The family of Andrea Mariano of Thornhill, Ontario indicated the cause of her death was anaphylaxis. While they provided no details as to the likely allergen trigger, Allergic Living magazine reports that Ms Mariano was known to have a severe peanut allergy.
The Queen’s University website stated that flags on campus will be flown at half-staff and that grief counseling is available through the University’s health services. Our deepest sympathies go out to the Mariano Family and friends of Ms Mariano.
We know that many parents of young adults with food allergies are concerned as they send their children off to school. We urge you to take every opportunity to remind them to protect themselves by following some basic guidelines:
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Last week, Lianne Mandelbaum – founder of the No Nut Traveler blog – was featured on NPR’s Here & Now to discuss the difficulties of traveling by air with a severe peanut allergy.
Lianne describes the need for early boarding, buffer zones, and stock epinephrine on every flight. The 10 minute segment entitled A Push To Make Flying Safer For People With Peanut Allergies is well worth the time and you can listen to it here:
ABC News Australia reports that a study of hospital admissions in the country from 2005 to 2013 found a 50% jump in children admitted for anaphylaxis.
Professor Mimi Tang of the Murdoch Children’s Research Institute (MCRI) said the highest rates of hospital admission were for younger children, but that rates for older children aged 5-14 more than doubled.
“What we think is happening is that more children are getting food allergies but of concern, these allergies tend to be peanut, tree nut and shellfish that you don’t grow out of,” she said.
In a study to be presented at the ongoing American Thoracic Conference (ATS) 2015, it was determined that many children suffering from asthma have a sensitivity to peanuts but their families are unaware.
“Many of the respiratory symptoms of peanut allergy can mirror those of an asthma attack, and vice versa. Examples of those symptoms include shortness of breath, wheezing and coughing,” said study lead author Robert Cohn, MD, MBA. “This study aimed to evaluate the proportion of asthmatic children who also demonstrated a sensitivity to peanuts.”
The study researched the charts of 1517 children diagnosed with asthma at Mercy Children’s Hospital in Toledo, Ohio. Of the charts reviewed, 665 (43.8%) had IgE testing for peanuts, and of this group 148 (22.3%) had positive results.
Of the children with positive IgE tests, more than half (53%) of the children and their families did not suspect there was any sensitivity to peanut.
A study of the accidental exposure of children with physician-confirmed peanut allergy was published in the Journal of Clinical and Translational Allergy earlier this month.
The parents of 1941 children were recruited from Canadian allergy clinics and allergy advocacy organizations over a ten year period beginning in 2004, who completed questionnaires regarding the accidental exposure to peanuts of their children over the preceding year and the results were correlated.
One question we often field generally reads something like this:
This product has a statement that says “Contains: Wheat” but doesn’t mention anything about the peanut oil listed as an ingredient! If I wasn’t such a careful label reader I would have missed it entirely! Should I report them?
Irate in Indiana
To answer questions like Irate’s, we need to take a close look at a clause in Section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004 – often referred to as FALCPA, the law that mandates how food products must be labeled with regard to allergens.
Here’s the clause in question (with the emphasis ours):
The term `major food allergen’ means any of the following:
(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.
(2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following:
(A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil.
(B) A food ingredient that is exempt under paragraph (6) or (7) of section 403(w).”.
So highly refined oils are exempt from the allergen labeling regulations mandated by FALCPA.
Well, we know the Dowager Countess of Grantham (our favorite character from Downton Abbey) is highly refined, but what exactly are highly refined oils and why are they treated differently from the foods from which they are derived?
In a nutshell, highly refined oils are edible oils “resulting from a process that involves de-gumming, neutralizing, bleaching, and deodorizing the oils extracted from plant-based starting materials such as soybeans and peanuts.”
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In positive news, DBV Technologies, a French firm developing skin patch therapies for various allergens, issued a press release announcing their Viaskin® Peanut patch has received “Breakthrough Therapy” (BT) designation from the US Food and Drug Administration (FDA).
DBV describes Viaskin as “an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.”
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