Most of us are certainly aware that the number of people with severe food allergies is increasing rapidly. But there is hope for the future, as an advisory panel at the Food and Drug Administration (FDA) recently voted to approve a new treatment for peanut allergies in children. Called Palforzia, the drug seeks to treat peanut-allergy sufferers by exposing them to increasing amounts of pharmaceutical-grade peanut protein.
FOOD ALLERGIES have plagued humans for thousands of years. In the fifth century BC Hippocrates noted that although some people could eat their fill of cheese “without the slightest hurt…others come off badly.” The difference, he observed, “lies in the constitution of the body.”
There is justice at last, with Mylan, the maker of EpiPens, being fined $30 million for over charging Medicaid by classifying it as a “generic” drug, rather than a branded one. Also, investors were kept in the dark about Mylan’s EpiPen misclassification and the potential loss Mylan faced as a result of the pending investigation.
The Securities and Exchange Commission today announced charges against Pennsylvania-based pharmaceutical company Mylan N.V. for accounting and disclosure failures relating to a Department of Justice (DOJ) probe into whether Mylan overcharged Medicaid by hundreds of millions of dollars for EpiPen, its largest revenue and profit generating product. Mylan agreed to pay $30 million to settle the SEC’s charges.
As noted in the previous article, whenever a company owns 90% of a product’s market share, it can create havoc when there are quality issues causing supplies to dwindle. Sanofi was a competitor of Mylan’s EpiPen, and lost so much money due to Mylan’s alleged unfair selling practices that they turned the rights back to Kaléo in 2016. Now Sanofi is suing Mylan for erecting barriers such as not allowing insurers and pharmacies to get rebates if they offered reimbursement for Sanofi’s product, Auvi-Q. Fortunately, Kaléo re-introduced Auvi-Q to the market in 2017.
Prompt administration of epinephrine can mean the difference between life and death for a food allergy sufferer experiencing anaphylaxis, a severe, sometimes fatal reaction to an allergen. That’s why those that have been diagnosed with an allergy to specific foods are encouraged to carry two epinephrine auto-injectors with them at all times, wherever they go.
Back in 2015, there were three epinephrine auto-injectors approved for the US market: EpiPen by Mylan — by far the dominant product with a 90% market share — Adrenaclick by Impax, and Auvi-Q, a relatively new entrant at the time manufactured and marketed by Sanofi.
It’s always nice to reward people who go well above the call of duty to make the world a better (and safer) place. Dr. Jeremy Cushman, who will be presented with the John J. Condemi award, helped to implement the Check and Inject program that allows EMTs to administer epinephrine using a vial and syringe. This program is saving thousands of dollars every year and has increased awareness of anaphylaxis and the role epinephrine plays in saving lives.
Our Ruth T. Cornell award will be presented to Jamie Kosten who saved is father’s life by administering epinephrine after his father was stung by a bee. Congratulations to both!
Honoring Those Who Save Lives, Dr. Jeremy Cushman and Jamie Kosten
By Suzanne Driscoll September 9th, 2019
On Thursday October 10th the Allergy Advocacy Association will hold our second annual Action Awards Gala. Our association will honor Jeremy Cushman MD and Jamie Kosten; Dr. Jeremy Cushman will receive the John J. Condemi award and Jamie Kosten will receive the Ruthie T. Cornell award.
Two men could hardly be more different than Jeremy and Jamie. One is a grown man with many years as a practicing physician. The other is a young man working his way towards graduation from McQuaid Jesuit High School. Both men, however, have aided individuals at risk for anaphylaxis in two very unique ways. And saved lives, too!
There is yet another approach to desensitizing those who are allergic to peanuts. Instead of having patients ingest peanut protein as in oral immune therapy, doctors using Sublingual immunotherapy (SLIT) place a small amount of peanut protein under patients’ tongues. Because the peanut protein goes immediately to the blood stream and avoids digestion, patients can be given much smaller amounts that will hopefully avoid serious side effects.
Source: University of North Carolina Health Care Date: September 4, 2019 Summary:
Sublingual immunotherapy (SLIT) trial participants tolerated between 10 and 20 times more peanut protein than it would take for someone to get sick. Researchers say SLIT provides a good cushion of protection with an easy mechanism (tiny bit of liquid under the tongue) and a strong safety signal.
People allergic to peanuts may have a new way to protect themselves from severe allergic reactions to accidental peanut exposure. It's called sublingual immunotherapy — or SLIT — and it involves putting a miniscule amount of liquefied peanut protein under the tongue, where it is absorbed immediately into the blood stream to desensitize the immune system to larger amounts of peanut protein.