Allergies come in all shapes and sizes ...
Just like allergy sufferers. And they are on the rise. For many people allergies can range from sniffling and sneezing to skin rashes to gastrointestinal issues. A certain percentage, however, have more than these uncomfortable symptoms to deal with. Anaphylaxis, a serious life-threatening reaction, causes approximately 1,500 deaths a year in the United States alone. Clearly, allergies are nothing to sneeze at!
Articles for Advocacy
The need for a treatment for peanut allergies becomes more apparent when a recent study showed that those living with an allergy to peanuts have almost double the annual healthcare costs for patients who didn’t have a peanut allergy. Out of 42,000 people studied, 36% of the peanut allergy patients had experienced anaphylaxis and 33% had visited an emergency department, compared to 20% of those without a peanut allergy.
Study Shows High Costs and Burden of Peanut Allergy
By: Gwen Smith
February 6, 2020
A study of a large U.S. health insurer database reveals the high dollar and health costs for those living with peanut allergy.
Using the IBM MarketScan Commercial Claims and Encounters Database, researchers analyzed insurance claims for almost 42,000 patients with peanut allergy between January 2011 and September 2015. They found that:
-The yearly “all-cause” healthcare costs for patients who had a peanut allergy diagnostic code was $6,400 a year. That was almost double the “all-cause” annual healthcare costs ($3,500) for patients who didn’t have the peanut allergy code.
We’re all familiar with the Epi-Pen© for the treatment of a life-threatening allergic reaction, and now a “first of its kind” oral sublingual film formulation that delivers epinephrine systemically is in development for the treatment of anaphylaxis. The FDA recently said that that no additional studies would be necessary prior to opening the proposed Investigational New Drug (IND) Application for AQST-108. The Administration indicated that there appears to be an unmet medical need among patients who resist the standard of care use of intramuscular injection (epinephrine auto-injector) in the treatment of anaphylaxis, and that AQST-108 may potentially address some of those unmet needs.
“First of Its Kind” Oral Treatment of Anaphylaxis
FDA Opens Door for Clinical Development of Aquestive Therapeutics Anaphylaxis Treatment
By News Wire ~ 3rd Party Press Release
2020/02/06
-Pre-IND Meeting on AQST-108 Completed
-FDA Confirmed AQST-108 To Be Reviewed Under 505(b)(2)
-No Additional Clinical Studies Would Be Required Prior to Opening Proposed IND
-Pivotal Pharmacokinetic (PK) Clinical Trials Planned To Be Initiated Before Year End 2020
If defibrillators are required on every airliner, why not an epinephrine auto-injector? Despite resistance from the airline industry, two U.S. Senators and a Representative recently urged the Federal Aviation Administration (FAA) to require that U.S.-based commercial airlines include EAI devices in their onboard emergency medical kits (EMKs). Rep. Khanna of California has been particularly supportive in leading the campaign for greater funding into allergy research and treatment options. She helped secure an increase of $362 million in funding for the National Institute of Allergy and Infectious Disease (NIAID) with a directive to invest in food allergy research, and an additional $10 million for the Peer-Reviewed Medical Research Program (PRMRP) under the Department of Defense.
“This Is A Simple Step That Will Undoubtedly Save Countless Lives.”
Rep. Khanna, Senators Duckworth & Schumer Urge FAA to Require EAI Devices On Every Airliner
Press Release
February 7, 2020
Washington, DC – Today, Rep. Ro Khanna (CA-17), Sen. Tammy Duckworth (D-IL) and Minority Leader Chuck Schumer (D-NY) urged the Federal Aviation Administration (FAA) to require that U.S.-based commercial airlines include epinephrine auto-injectors in their onboard emergency medical kits (EMKs).
In their letter, sent this week after the FAA shared the Aerospace Medical Association (AsMA) recommendations for EMK contents, Khanna and Duckworth commend this first step by the FAA and also called on the agency to move forward and modernize the required content list for onboard EMKs to include epinephrine auto-injectors, as recommended by AsMA.
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