Peanut Allergy Treatment Product Approved by the Food and Drug Administration

The first drug for the treatment of peanut allergy — which currently affects greater than one million children in the United States alone — was officially approved by the Food and Drug Administration of the United States on Friday, January 31, 2020.

Peanut Allergy Treatment Product Approved by the Food and Drug Administration

A final decision pertaining to the approval of Palforzia for public use was expected at the conclusion of the formal approval process, as seven out of nine members of an advisory committee for the Food and Drug Administration of the United States voted on Friday, September 13, 2019 to approve Palforzia for peanut allergies and bringing this controversial standardized peanut powder treatment product to becoming widely available for people who are allergic to peanuts.

Aimmune Therapeutics is the biopharmaceutical company which developed Palforzia, which is supposed to help reduce allergic reactions to peanuts for patients between four years old and 17 years old as part of oral immunotherapy protocol — but it will not be easy to obtain, as Palforzia “is available only through a Risk Evaluation and Mitigation Strategy”, according to this official news release from the headquarters of the company in California.

The treatment will not be inexpensive, either, as the list price is expected to cost approximately $890.00 per month — although the actual cost to patients will depend on their health insurance policies.

Because no other treatment for peanut allergies is currently approved by the Food and Drug Administration, the only solution for people who are allergic to peanuts is to avoid them as much as possible — which can be especially difficult as a passenger aboard an airplane.

One reason why Palforzia is controversial and being watched closely is because of concerns raised in some of the testimony that the treatment could actually lead to more allergic reactions, as found on page 4 in this briefing document — which contains information in greater detail — of the meeting of members of the Allergenic Products Advisory Committee for the Food and Drug Administration:

Palforzia treated subjects in the pediatric safety population reported an increased number of allergic reactions, including systemic allergic reactions, compared to placebo-treated subjects. A total of 9.4% subjects taking Palforzia had a systemic allergic reaction during initial dose escalation and up-dosing compared to 3.8% of placebo subjects. This imbalance was seen during maintenance as well with 8.7% of Palforzia treated patients having a systemic allergic reaction compared to 1.7% of placebo-treated subjects. During the maintenance period, 7.7% of Palforzia treated subjects usedepinephrine compared to 3.4% in the placebo group. Twelve subjects treated with Palforzia were diagnosed with eosinophilic esophagitis (EoE) in the entire clinical development program while no subjects in the placebo group of the controlled safety population received a diagnosis of EoE. Similar safety data are seen in the adult population with respect to systemic allergic reactions.

Those severe allergic reactions can develop quickly — sometimes within seconds — and range from hives, redness or swelling of the skin to digestive discomfort to such dangerous reactions as constriction of the throat and airways and loss of blood flow to vital organs.

Peanut allergy is the most common — and among the most dangerous — food allergy among children, as it has been increasing in recent years: almost 2.5 percent of children in the United States are currently estimated to be allergic to peanuts; and approximately 20 percent of children who are affected by peanut allergy are sent to emergency rooms every year due to accidental exposure to peanuts.

Additional information pertaining to Palforzia is available from the official Internet web site of the Food and Drug Administration of the United States — as well as from the official Internet web site of the peanut powder treatment drug itself.

Summary

What is important to note is that Palforzia will not cure or remove a peanut allergy, as oral immunotherapy can only render peanut allergies to be more manageable by supposedly helping to reduce allergic reactions to peanuts for patients between four years old and 17 years old.

It also is not indicated for the emergency treatment of allergic reactions — including a sudden and potentially deadly condition known as anaphylaxis, which requires immediate attention and treatment, according to this article from the American College of Allergy, Asthma and Immunology.

I have written extensively over the years pertaining to food allergies in the form of articles posted here at The Gate — including:

Photograph ©2015 by Brian Cohen.

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