The FDA is getting closer to the approval of Palforzia's allergy to peanut allergy treatment

A treatment for peanut allergies that would be the first of its kind to get 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 has been developed by Aimmune Therapeutics and is intended for patients aged 4 to 17 years.

Oral immunotherapy is essentially an exposure therapy. Patients are exposed to minute but increasing amounts of allergens for several months and often notice an improvement in their reactions. Doctors have been prescribing peanut flour in this way for years.

Palforzia is different because it is a standardized version of this therapy that aims to be the first of its kind to get FDA approval. Its availability would probably mean that more and more people with peanut allergies would try oral immunotherapy to improve, but not cure, their condition.

Peanut allergies have become more common in recent years (2.2% of American children are now allergic to legumes), so a product like Palforzia would be a welcome option for children who fear accidental exposure (and their parents) .

That being said, there is controversy surrounding the drug that could still be a barrier to FDA release.

"I think that, based on the data we presented, neither safety nor efficacy has been demonstrated," said Dr. John Kelso, Allergy Specialist at Scripps Clinic. San Diego, to NPR.

Some experts go even further, suggesting that oral immunotherapy could lead to an increase in allergic reactions in some cases. Until now, research shows that the risk of anaphylactic reaction could be increased three-fold as the patient acquires tolerance before going to the maintenance dose, the last stable dose needed to maintain the effects. positive effects of immunotherapy.

The same group that approved Palforzia voted 8-1 to approve a risk assessment and mitigation strategy that includes measures that drug manufacturers should take to ensure the safety of their patients. Among these steps: a requirement that all Palforzia patients must have an epinephrine auto-injector – think EpiPen – at hand in case of a serious allergic reaction.

Despite these cautious reasons, the committee's approval brings a potential treatment closer to the market and, possibly, the pharmacy cabinets of parents of children with peanut allergy.

The FDA will vote on the final approval of the drug next year.