A treatment for peanut allergies that would be the first of its kind to gain FDA approval took a huge step forward on Friday when an advisory committee voted 7-2 in favor of its approval.
Palforzia is a standardized, medical-grade version of an oral immunotherapy treatment. It was developed by Aimmune Therapeutics and is meant to be used by patients between the ages of 4 and 17.
Oral immunotherapy is basically exposure therapy. Patients are exposed to tiny but increasing amounts of an allergen over several months, and they often find that their reactions improve. Doctors have been prescribing peanut flour in this way for years.
Palforzia is different because it’s a standardized version of this therapy that’s aiming to be the first of its kind to gain FDA approval. Its availability would likely mean more and more peanut allergy sufferers would try oral immunotherapy in order to improve—but not cure—their condition.
Peanut allergies have become more common in recent years—2.2 percent of American children are now allergic to the legume crop—so a product like Palforzia would be a welcome option for kids who live in fear of accidental exposure (and their parents).
That being said, there is some controversy surrounding the drug that may still pose as an obstacle to FDA release.
“I think from the data that we have had presented to us that neither the safety nor efficacy have been demonstrated,” said Dr. John Kelso, an allergy specialist at Scripps Clinic in San Diego, told NPR.
Some experts go even further, suggesting that oral immunotherapy could lead to increased allergic reactions in some cases. Research so far shows that it might triple the risk of an anaphylactic reaction during the time a patient is building tolerance on the way to the maintenance dose, the final, steady dosage needed to maintain the positive effects of immunotherapy.
The same panel that approved Palforzia voted 8-1 to approve a Risk Evaluation and Mitigation Strategy with steps drugmakers would have to take in order to ensure the safety of their patients. Among those steps: a requirement that all Palforzia patients have an epinephrine autoinjector—think EpiPen—on hand in case of a severe allergic reaction.
But despite these reasons for caution, the panel’s approval brings a potential treatment one step closer to the marketplace and, eventually, the medicine cabinets of parents with kids who struggle with a peanut allergy.
The FDA will vote on the drug’s final approval next year.