Economy

First Drug Treatment for Peanut Allergy Receives FDA Approval

First Drug Treatment for Peanut Allergy Receives FDA Approval”

The goal, the company says, is to get allergic children and teens to the point where accidental exposure to small amounts of peanuts do not trigger a potentially life-threatening immune response. Palforzia can not be used for the emergency treatment of allergic reactions, including anaphylaxis.

The Food and Drug Administration has approved the first treatment for children with peanut allergies.

Kids who live with peanut allergies, which can have consequences ranging from annoying to fatal, now have an approved form of pharmaceutical relief, the FDA announced Friday night.

Since the drug doesn't eliminate the chances of suffer anaphylaxis, in order to receive the treatment, parents, caregivers and patients should still have injectable epinephrine on their person at all times.

The approval comes months after an independent panel of experts to the FDA backed the allergy therapy but raised concerns about the risk of severe allergic reactions it poses to young patients.

To be sold as Palforzia, the product consists of purified peanut proteins, to be administered in carefully controlled escalating doses.

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Palforzia is suitable for people ages 4 to 17, but the FDA warns that patients using it must continue avoiding peanuts in their diet. The Initial Dose Escalation phase is given on a single day. Up-dosing takes place over several months.

"Peanut allergy carries an overwhelming psychosocial burden that impacts patients and their families daily - peanuts are everywhere, and the threat of a severe reaction related to an accidental peanut exposure dominates families' daily lives", said Lisa Gable, Chief Executive Officer of the Food Allergy Research and Education (FARE), in Aimmune's press release.

At the start of the study, the equivalent of one-third of a peanut kernel triggered an allergic reaction in Noah.

The results showed that 67.2% of Palforzia recipients tolerated a 600 mg dose of peanut protein in the challenge, compared to 4.0% of placebo recipients.

The safety of the medication was assessed in 2 double-blind, placebo-controlled studies in approximately 700 peanut-allergic individuals. Palforzia should not be administered to those with uncontrolled asthma. The FDA requires patients to take their first dose and each increased dose under supervision in a certified health center, and doctors and their patients must enroll in a special safety program, the AP reported.

FARE raises money to support research into food allergy treatments, and was one of the organizations that called for an FDA-approved oral immunotherapy back in 2011, Gable added.



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