When Megan Salch’s daughter, Kylie, was just shy of 2 years old, the Garden Oaks mom gave her a saltine with peanut butter on it as Kylie’s pediatrician had recommended holding off on peanuts until this time. Kylie’s reaction was immediate and it necessitated a trip to the emergency room.
“When your child is that allergic, it is terrifying,” Salch said.
Kylie is not alone. Peanut allergies affect an estimated 1.2 percent of the overall U.S. population and about 2.5 percent of the pediatric population, according to the American Journal of Managed Care. The Journal said they are the most common food allergy in children, affecting about 25 percent of those with a food allergy, and are a leading cause of allergy-related death in children.
That’s why the announcement about Palforzia, the first FDA-approved drug for treating peanut allergy with oral immunotherapy – meaning a small dose of the allergen can be swallowed instead of given by injection – was such big news.
For her part, Salch is both cautious and hopeful.
That’s because Kylie – now 14 – finished a three-year peanut desensitization study at Texas Children’s Hospital last summer. The FDA-approved study involved ingesting peanut flour and then peanuts in increasing doses under medical supervision. The family travelled every other week to the hospital.
“It was a very long and very trying three years,” Salch said.
It was heartbreaking as well, because after a wash-out period of a month in which study protocol dictated that Kylie go peanut free for a month and then eat peanuts again, she had a reaction on the first one. For now, the family is still figuring out its next steps.
“With (Palforzia), it seems the ramp-up period is less stressful,” Salch said. “And it still gives people the promise of more protection.”
Executives from Aimmune Therapeutics, which developed the drug, told the Associated Press that their hope is that it will be “a matter of weeks” before doctors can start prescribing the drug. The treatment’s list price is $890 a month, with insurance covering a portion of that cost. Aimmune said it will work with insurance companies for coverage, and will offer a patient co-pay assistance program.
The Leader spoke with Dr. Aikaterini Anagnostou, director of the Food Immunotherapy Program at Texas Children’s Hospital and Associate Professor of Pediatric Allergy, Baylor College of Medicine to get her thoughts about the drug. Anagnostou also treated Kylie Salch.
“The availability of the first approved drug for treating peanut allergy with oral immunotherapy is a major advancement in the field of food allergies,” Anagnostou said. “Peanut-allergic patients will now have access to active management options and a standardized treatment for their food allergy.”
Anagnostou said increasing daily doses of Palforzia are given over several months, under medical supervision, with the aim to achieve “desensitization” – which is the ability to tolerate larger doses of peanut over time with ongoing daily treatment.
“Most peanut-allergic patients are able to undertake oral immunotherapy treatment, but there are certain contraindications to the drug, so not everyone will be eligible,” Anagnostou said. “This will need to be discussed with your allergist on an individual basis.”
The AP’s story noted that the side effects include occasional severe allergic reactions. The FDA will require doctors and their patients to enroll in a special safety program, and patients will take Palforzia under supervision in a certified health center. The drug must be taken at the correct daily dose to keep their protection.
Anagnostou stresses that kids will still need their EpiPen, even if they are taking the drug.
“Emergency medication must always be available with the patient as allergic reactions can occur during oral immunotherapy,” she said. “The drug will not cure the peanut allergy, but will provide protection from accidental exposures.”
Tests to create similar drugs for eggs, milk and tree nuts are ongoing, according to the AP.
Anagnostou said that once Palforzia becomes available in the market, Texas Children’s Hospital will offer it.
While the Salch family was disappointed that Kylie is still vulnerable, they are proud that her sacrifice and time – as well as that of other study participants across the country – is what gives companies the data to develop new drugs like Palforzia.
“Other drugs will come along, too, and hopefully the costs will go down so that many more people can be helped,” Megan Salch said.