Families affected by peanut allergies— which are often severe, especially for children— now have the opportunity to receive treatment from a drug recently approved by the U.S. Food and Drug Administration.
The drug, Palforzia, stems from an 18-year research effort from the Arkansas Children’s Research Institute on the campus of Arkansas Children’s Hospital in Little Rock.
The drug is the first to be approved by the FDA to treat peanut allergies in children. Dr. Stacie Jones, Professor of Pediatrics at University of Arkansas for Medical Sciences and director of Arkansas Children's Hospital's Food Allergy Program, said she's excited to see 18 years of research pay off.
“We began these studies in peanut oil immunotherapy about 18 years ago in our center here in collaboration with the center at Duke, and an investigator named Dr. Wesley Burks there,” Jones said.
In its initial stages, the research explored oral immunotherapy to treat egg allergies, and later expanded to include allergies to peanuts.
More research centers began to emerge, and eventually and independent company, Immune Therapeutics, conducted several studies with 500 children to develop an oral immunotherapy specifically for peanut allergies.
Palforzia, the new peanut allergy drug that emerged from these intensive studies and research, is oral immunotherapy, which exposes children to "peanut powder highly characterized and purified by the manufacture, and it is delivered in a food substance, like applesauce or pudding," Jones said.
Children take small controlled doses of the powder, which gradually desensitizes them to peanuts in a way that does not put them at risk for reaction. Jones said dosage occurs in three phases.
“There’s an initial dose escalation, where a child will come in to our resesach unit or to our clinical unit, and they will be given several doses in tiny quantities of the peanut that they’re allergic to that is subclinical, so less than they would have a reaction to.
"Over the next five or six months, they will come in every two weeks to receive a buildup dose until they reach a 300 milligram peanut protein dose, which is equivalent to about one peanut. At that point, they are relatively desensitized. We usually then keep them on that therapy indefinitely,” Jones said.
While Jones says Palforzia is revolutionary in its accessibility, it is personalized medicine just like anything else— and is not for everyone.
"It’s not a therapy that provides a cure, but it provides protection against reactions."
Like any other medicine, dosage and frequency may vary depending on individual patient needs. Even though the drug is in its final stages of research, patients cannot obtain a prescription yet; it will take two to six weeks to get material ready for manufacturing and distribution.
The launch will likely be in the coming weeks or couple of months, and then the drug will be available on the market.