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A focus group on the Food and Drug Administration is responsible for evaluating the safety and efficacy of a peanut allergy treatment and whether or not to recommend drug approval.
A new peanut anti-allergy treatment will be reviewed Friday by Food and Drug Administration advisors, who will determine whether the drug's ability to desensitize children to life-threatening allergies outweighs its side effects. If approved, this would be the first of what should be a wave of new food allergy medications that prevent a reaction, rather than just treating one after.
After one year of treatment with this drug, Palforzia, most children participating in a large trial could tolerate the equivalent of two peanuts. But the drug has had a number of side effects, including an increase in allergic reactions and the need to inject epinephrine with a pen to calm down systemic responses. Therapy is not a cure. people will still have to avoid peanuts and get emergency medicine.
Palforzia, manufactured by the biotechnology company Aimmune Therapeutics, aims to reduce reactions when people are inadvertently exposed to peanuts, for example when consuming a food that has been cross-contaminated. The company is seeking authorization to administer the drug to children aged 4 to 17 years old.
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"For a very anxious family, who is allergic to peanuts and is concerned about not living with this allergy, it could provide additional safety," said Marcus Shaker, pediatric allergist at the Geisel School of Medicine in Dartmouth. . the trial. "They will always need to strictly avoid peanuts, but [this will help] to give up some of the fear that they may have.
The deliberations of the committee will be followed closely, not only because it represents the first treatment of peanut allergy, but also because the treatment, essentially a pharmaceutical grade peanut protein capsule , should be the first of a new generation of food allergy treatments that work by gradually increasing the exposure of people to the allergen. The advisory committee's recommendation will guide the agency's decision to approve the treatment, but is not binding.
Despite the excitement, the allergists said the treatment might not be suitable for all patients. Treatment requires repeated visits to the office and regular medication that can trigger, in the short term, the side effects that it aims to prevent.
In a large trial involving 551 people, including 496 children, one in 10 people who received the drug dropped out due to adverse events, including abdominal pain, vomiting, and vomiting. systemic allergic reactions. In this trial, 14% of patients taking this medication had to use an epinephrine pen to suppress a severe reaction, more than double that of a placebo.
"I think that's not necessarily the case for all peanut-allergic patients. What I'm going to do, and a lot of allergists, we're going to have in-depth conversations with our patients to find out if it's something that interests them, "said Hemant Sharma, head of the allergy and immunology division at Medical Center national for children, involved in the trial.
Shaker said it remained to be seen if patients would accept the increase in allergic reactions for the protection it confers against accidental exposure.
"I think we need more data on what this will mean for patients and how it will change their level of risk perception and quality of life," said Shaker. He said the drug is "a bit sweet and sour for everyone. Everyone is happy to see something happen, and yet that's not what we asked Santa Claus. "
Some doctors are already using increasing doses of inexpensive peanut flour to desensitize allergies, but federal approval of a drug would likely be covered by insurance and would expand the use of the drug. 39; approach. Immigrant scientists say that an approved drug will also eliminate uncertainties about the dosage of commercially available groundnut flour.
Steve Tilles, director of medical affairs at Aimmune, said that it was not yet known how long patients would stay on treatment, but he hoped that after a few years of treatment, people could interrupt treatment while remaining insensitive to health. peanuts.
Aimmune is also working on a therapy for egg and nut allergies. Other researchers are working on a skin patch to treat peanut allergies or to administer a drug under the tongue.
Aimmune did not provide any information on the cost of the drug, but a recent analysis of ICER, a drug-price-focused surveillance organization, concluded that it was unlikely that the drug would be available. There was not enough evidence that this drug was more beneficial than just avoiding peanuts.
Read more:
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