First Peanut Allergy Rx Approved

FDA approves Palforzia to prevent allergic reactions to peanuts in children

(RxWiki News) The first medication to prevent peanut allergies in children has received a green light from the US Food and Drug Administration (FDA).

This new approval is found under the names Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. The FDA approved this medication to prevent allergic reactions to peanuts in children who are between the ages of 4 and 17 and who have been diagnosed with a peanut allergy.

This medication is approved to help prevent allergic reactions to peanuts, including anaphylaxis, in children due to accidental exposure.

The FDA noted that anyone who takes this medication should also try to avoid peanuts in their diets.

“Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy," said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. "Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions ... When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy."

Palforzia is not approved to provide emergency treatment of allergic reactions, according to the FDA.

This medication is available as a powder made from peanuts. The powder is mixed with a small amount of food before administration. Examples of food that this medication can be mixed with include applesauce and yogurt.

This medication's dosing includes three phases:

  • Initial Dose Escalation Phase - Given on a single day
  • Up-Dosing Phase – Requires 11 increasing dose levels (This phase typically lasts several months.)
  • Maintenance Phase - Daily dose

During the first two phases (specifically the Initial Dose Escalation and the first dose of each Up-Dosing level), administration and supervision by a health care professional in a certified health care setting is required. This requirement is in place to ensure severe allergic reactions can be identified and treated if they do occur.

Common side effects of Palforzia may include stomach pain, nausea/vomiting, tingling in the mouth, itching (including in the mouth and ears), throat irritation/tightness, hives, shortness of breath and even anaphylaxis.

Those who have uncontrolled asthma should not take this medication, the FDA noted.

Because there is a risk of anaphylaxis with this medication, the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) to go along with this drug. This requirement includes several components to ensure safe use. These components include the following:

  • This medication is only available to patients through certified health care providers, health care settings and pharmacies that are enrolled in the REMS program. Furthermore, these providers and health care settings will need to be educated on the risk of anaphylaxis.
  • Administration in a certified health care setting is required for the Initial Dose Escalation phase and first dose of each Up-Dosing level.
  • Patients and caregivers will need to be educated on the need to have injectable epinephrine available at all times.
  • Patients need to avoid peanuts in their diets.
  • Patients and caregivers will need to know how to recognize the signs and symptoms of anaphylaxis.

This new approval was granted to Aimmune Therapeutics.

Speak with your health care provider if you have any questions.

Written by Anyssa Garza, PharmD, BCMAS