In this edition of Ron’s Clinical Corner, I will be discussing new treatment options for the management of peanut allergies in children and adolescents.
It is estimated that approximately 1.25 million children and adolescents in the U.S. have a peanut allergy, with an annual incidence of accidental exposure of around 13%. Studies have shown that food-related allergies have an impact on both social and family activities based on the risk and severity of reactions with accidental exposures. The current standard of care for food-related allergies has been strict avoidance and treatment with epinephrine products for accidental exposures.
There are many approaches to peanut allergies being studied including using extracts or monoclonal antibodies. Two products, Palforzia® by Aimmune Therapeutics and Viaskin Peanut® from DBV Technologies, have emerged as potential treatment options. Palforzia® is a peanut derived powder given orally to increase an individual’s tolerance to peanut allergens, providing protection from potentially life threatening exposures. Viaskin Peanut® is a transdermal patch that delivers peanut allergy protein through the skin to specific cells, bypassing absorption into the bloodstream. Since Viaskin Peanut® avoids allergen in the bloodstream, it is thought that it may have a better safety profile due to limiting the overall exposure to the peanut-allergy protein.
Although the two medications have been studied for children and adolescents, they vary regarding the age ranges they treat (Palfozia® for individuals 4-17 years old and Viaskin Peanut® in ages 4-11). While Palforzia® may appear to have better efficacy than Viaskin Peanut®, it may also have a higher incidence of adverse effects (based on what was discussed above). Both products require a maintenance dose indefinitely in order for desensitization to continue. In addition, both products will require that those being treated have access to epinephrine in case of adverse effects or accidental exposure.
On September 13, 2019, the FDA Allergenic Products Advisory Committee met and voted 7-2 in favor of Palforzia® regarding risk-vs-benefit in the treatment of peanut allergies. It should be noted that there was some commentary by panel members acknowledging that the medication may not be perfect or ideal for everyone. They also suggested that individuals and parents should consider the risks and benefits before pursuing treatment. The FDA is also requiring a Risk Evaluation Mitigation Strategy (REMS) program for Palforzia®, which would require additional documentation and attestations. Although the endorsement by the advisory committee does not ensure the FDA will approve the medication, it does suggest they may follow the recommendation to bring the drug to market. DBV Technologies has submitted the application for Viaskin Peanut® to the FDA for review. At this time, there is no data available that allows us to forecast what the potential future for this medication will be.
Along with the two medications mentioned above, there has also been an investigation into monoclonal antibodies as a potential treatment option for food-related allergies. Currently these medications are still in early stages of development and/or are undergoing early to mid-stage clinical trials to access safety and efficacy profiles. It is encouraging to see the development of medications used for food-related allergies. While not free from potential adverse effects, Palforzia® and Viaskin Peanut® may offer an option for certain individuals with peanut-protein allergies. We do not have the specific pricing on either product. There have been some reports suggesting that the annual cost for treatment for Palforzia® and Viaskin Peanut® could be around $5,000 or more depending on dose.
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