UPDATE: Lawsuits against Brand Name and Generic Pharma Companies Move Ahead

Are you ready to join a class action suit against “Big Pharma” for trying to monopolize the epinephrine auto-injector market? A recent ruling by a US District Judge said that numerous lawsuits against the marketers and manufacturers of epinephrine auto-injectors may proceed as a nationwide class-action under a federal racketeering statute. Both brand name and generic drug companies allegedly tried to eliminate competition so they could raise prices by 500% or more. This ruling allows all persons and entities in the US who paid or provided reimbursement for Epi-Pens© as of August 24, 2011, to sue for damages under the federal Racketeer Influenced and Corrupt Organization (RICO) Act. Stay tuned for more details as they become available.

Mylan CEO Heather Bresch testifies before a U.S. House of Representatives Committee

Ruling Allows Millions to Join Lawsuit in Epi-Pen© Racketeering Case

By Dave Bloom
SnackSafely.com
2020/02/28

US District Judge Daniel Crabtree ruled yesterday that numerous lawsuits against the marketer and manufacturer of Epi-Pen© may proceed as a nationwide class-action under a federal racketeering statute. His ruling also allows consumers to sue for damages under state antitrust laws.

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Study: Co-Treatments Like Antihistamines and Probiotics Make Peanut OIT Success in Children More Likely

You’ve probably heard of the recent advances in Oral Immunotherapy (OIT) where patients are given very small amounts of peanut protein that do not trigger a reaction, and then increasing the dose over time to increase the amount the body can tolerate. A study by researchers from the University of Adelaide in Australia found that adding antihistamines and probiotics increase the success rate by 10%. Overall, the study found that the treatment worked in around 70% of children, so it might be worth asking your doctor for more information.

Study: Co-Treatments Like Antihistamines and Probiotics Make Peanut OIT Success in Children More Likely

brownish beige tablet in foreground

By  News Wire ~ 3rd Party Press Release
2020/02/07

Co-treatments like antihistamines and probiotics make successful de-sensitisation treatment of peanut allergy in children via oral immunotherapy 10 percent more likely, researchers from the University of Adelaide have found.

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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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How Reliable are Oral Food Challenge Results?

Speaking of Oral Immunotherapy (OIT), one mother is asking if her son ever passed an oral food challenge, how would she know if this was a reliable result — and not just a good immune system day? An allergist replies that there are many variables that influence the reaction from ingesting an allergen, but he feels confident that it would be safe to add food to the diet if it was shown to be tolerated during an oral food challenge.

How Reliable are Oral Food Challenge Results?

Doctor Speaking to a patient
Photo: Getty

By Dr. Scott Sicherer
February 12, 2020

Q: My son is 16, with multiple food allergies since he was a toddler. Over the years, he’s had four experiences with anaphylaxis, but food errors have mostly been confined to mild reactions. As his reactions vary, my question is: If my son ever passed an oral food challenge, how would he know if this was a reliable result — and not just a good immune system day?

Dr. Sicherer: One reason reaction severity may vary has to do with the amount of the allergen consumed.

For example, a person may have mild or even no symptoms with eating one peanut, but have severe symptoms if 15 peanuts are eaten.

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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

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

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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