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Peanut allergy treatment Palforzia gets green light from FDA committee: Shots



  An FDA committee voted to approve a new treatment for peanut allergies, Palforzia. Treatment is a form of oral immunotherapy designed to desensitize the immune system to peanuts.

LauriPatterson / Getty Images

  An FDA committee voted for approval of a new treatment for peanut allergies, Palforzia. Treatment is a form of oral immunotherapy designed to desensitize the immune system to peanuts.

LauriPatterson / Getty Images

A closely watched but controversial treatment of peanut allergies took a big step toward becoming more widely available.

On Friday, a US Food and Drug Administration advisory committee voted 7 to 2 to approve Palforzia, a Standardized Peanut Powder Product designed to reduce peanut allergic reactions in patients aged 4 to 17 as part of the oral immunotherapy protocol. The treatment was developed by the pharmaceutical company Aimmune Therapeutics.

"I voted 'yes' because I thought the data was pretty clear and I would actually compliment the sponsor on the size and caliber of the studies," Dr. Ira Finegold, professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.

The committee's vote could be a milestone in the fight against peanut allergies, for which there is currently no FDA-approved treatment. Allergy sufferers only have the choice to avoid peanuts. The FDA usually follows the recommendations of its advisory committees. A final decision is expected early next year.

The recommendation came despite the concerns expressed in some reports that treatment in some cases could actually lead to more allergic reactions.

"I also want my patients to be at a lower risk for reactions, but I believe from the data we have that neither safety nor efficacy has been proven," Dr. John Kelso, an allergy specialist at Scripps Clinic in San Diego.

Peanut allergies have increased in recent years. It is estimated that 2.2% of children in the US are allergic to peanuts. Oral immunotherapy does not cure these allergies but can make them easier to use for some patients. It is a regime where daily exposure to minute amounts of peanut powder is slowly increasing. Over the course of several months, many patients have seen a reduction in the frequency and severity of allergic reactions to small amounts of peanuts.

Palforzia offers a standardized medical version of the treatment that some doctors already offer using peanut meal.

The Committee also voted 8-to-1 to approve a risk assessment and mitigation strategy, which includes steps pharmaceutical manufacturers should take to ensure patient safety. These include requiring parents to immediately have an injectable epi-pen or similar device in place to reverse a potentially occurring reaction.

At a one-day meeting in Silver Spring, Maryland, scientists from Aimmune Therapeutics presented research findings on Palforzia, which was developed under the name AR101.

In a phase 3 study, the safety and efficacy of Palforzia were tested in numerous clinics in double-blind, placebo-controlled trials involving 551 participants aged 4 to 55 years

. Studies have shown that using oral immunotherapy with Palforzia can reduce reactions, Aimmunforscher also said that the treatment involves side effects such as nausea, itching in the throat and vomiting.

Research has also shown more serious risks, including tripling the risk (9.4% vs. 3.8% for placebo) of anaphylactic reactions during the time a patient builds tolerance to reach the maintenance dose. [19659006] However, some critics claim that Aimmune's data distort the security and effectiveness of Palforzia.

During the hearing, some members of the Advisory Committee on Allergens Products expressed concern that the data did not take into account the results of many patients who had discontinued the study due to discontinuation of studies.

"In my opinion, they can not be censored to fit in with your primary analysis, which mistakes people who do not make it, and I find that somewhat misleading," said Erica Brittain, statistician and deputy director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health in Bethesda, Maryland.

An independent review of oral immunotherapy has shown that children undergoing therapy have anaphylaxis with a probability of about 20%, compared with about 7% who took a placebo or avoided peanuts

from Aimmune researchers the need for more independent studies.

"Criticism on how best to analyze data is often best addressed by an independent monitoring committee or independent review committee with strong research methods and backgrounds, and often independent of those directly involved with the company," research sponsored "Chu said.

During the meeting, some committee members, including Dr. Randy Hawkins, a Phy A doctor at Charles Drew University in Inglewood, California expressed concern that white male patients dominated research, and asked whether non-white patients might have different results.

A public comment period included passionate statements from parents of children from across the country who had undergone oral immunotherapy and benefited from it. Many of them said their travel expenses had been paid by Aimmune.

These parents and patient representatives called on the committee to approve Paloforzia, as it was unacceptable to have no treatment option.

However, other experts argue that this is not the case. This is the case because physicians can already handle peanut meal from a grocery store.

"Some patients would probably prefer to use an FDA-approved product," Dr. Jay Portnoy, Children Mercy, Kansas allergist Member of the Advisory Committee on Urban, Missouri and Allergy Products, involved in the Paloforzia trials. He also offers oral immunotherapy with peanut meal.

"Other patients may choose not to worry about an FDA-approved product because peanut meal [obtained from grocery store] is very cost-effective, you do not need to obtain prior approval, you do not have to pay for your health plan." for this. "

But Dr. Soheila Maleki, a committee member and researcher at the US Department of Agriculture in New Orleans, argued that the Paloforzia provides the necessary standardization in oral immunotherapy that would improve safety.

The committee members also commented concerned about the lack of long-term data on Palforzia that would be needed throughout life to sustain the reduced response.


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