The Latest News About Palforzia©

Amidst all the celebrations that an effective new treatment for peanut allergies was approved by the Food and Drug Administration, high cost is a major concern. Called Palforzia©, the medication is very simply an exactly measured dose of peanut flour (!) in a very expensive capsule. Previously the only treatment was avoidance and then hoping that epinephrine was on hand after accidental ingestion. Read the article below and plan to have a conversation with your allergist to see if this new therapy might be right for your child. Hopefully insurance companies will provide adequate coverage for this important treatment.

AR101 Palforzia capsules

The First Treatment Approved by the FDA for Peanut Allergies

Edited by Jon Terry
February 10, 2020

The Food and Drug Administration has approved Palforzia©, the first medication for treatment of peanut allergies. Palforzia is the brand name of an oral immunotherapy (OIT) formerly known as AR101 while it was being developed and undergoing clinical trials.

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“First of Its Kind” Oral Treatment of Anaphylaxis

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

Woman holding up an Aquestive AQST108 Epinephrine Film

FDA Opens Door for Clinical Development of Aquestive Therapeutics Anaphylaxis Treatment

By  News Wire ~ 3rd Party Press Release

-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

WARREN, N.J., Feb. 06, 2020 (GLOBE NEWSWIRE) — Aquestive Therapeutics (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, announced today that it had a constructive face-to-face pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) for its drug candidate, AQST-108, a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis using Aquestive’s proprietary PharmFilm® technologies.

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Governor Cuomo Enacts "Gio's Law"

You would think that first responders would always have epinephrine on hand to use in an emergency anaphylaxis situation when every second counts. However that was not the case when Giovanni Cipriano had a severe allergic reaction to peanuts and could not be helped in time by first responders. His mother Georgina made it her life’s mission to pass “Gio’s Law” allowing police officers and firefighters to carry and administer epinephrine, signed into law last December. You can read the full story here.

Bill Signed Allowing Police and Firefighters to Carry and Administer Epinephrine

Georgina Cipriano Cornago - Photo by Neal P. Kemp

Edited by Jon Terry
January 12th, 2020

In late December, with the 2020 legislative session looming on the horizon, New York State Governor Andrew Cuomo signed "Gio's Law.” This law authorizes police officers and firefighters to carry epinephrine auto-injector (EAI) devices to treat people having dangerous allergic reactions in an emergency.

After years of advocacy by activists in NYS, "Gio's Law" will help first responders to more effectively treat an anaphylaxis emergency. EAI devices can be used to reverse allergic reactions (anaphylaxis) from bee stings, drug reactions, food allergies or exercise-induced shock. The most commonly prescribed device is Epi-Pen© the brand name made by Mylan Pharmaceuticals.

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“This Is A Simple Step That Will Undoubtedly Save Countless Lives.”

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.”

FAA logo

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). 

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Peanut Patch Therapy Led to Big Quality of Life Improvement for Families

It might seem obvious that taking steps to help avoid allergic reactions to peanuts would improve the quality of life for families with someone who has a severe allergy. But it’s nice to know that a scientific study backs this up. Children ages 8-12 participated in the Viaskin Peanut study where they were slowly exposed to their allergen through a patch that releases peanut proteins through the skin and stimulates the immune system. Participants must still practice peanut avoidance, but it will take a lot higher protein exposure to cause the treated patient to react.

Peanut Patch Therapy Led to Big Quality of Life Improvement for Families

Viaskin Peanut patch

By Gwen Smith
December 12, 2019

Desensitizing therapies are emerging for food allergies and being considered for approval by the FDA. But some in the medical community raise this question: Is desensitization, which is not a cure, enough to improve a food-allergic person’s quality of life?

A new study of families involved in DBV Technologies’ Viaskin Peanut patch therapy clinical trials gives insights into an answer. It found significant overall improvement in quality of life related to gaining greater peanut tolerance on the patch treatment. As well, questionnaires filled out by both children and parents showed quality of life gains in specific areas.

With parents, “the areas where we saw the most impact were the emotional impact, food-related anxiety, and social and dietary limitations,” Dr. Todd Green, DBV’s vice president of medical affairs for North America, told Allergic Living. In the children, aged 8 to 12, “when they were asked questions around avoidance or accidental exposure, that’s where that’s where they reported the most improvement,” he said.

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