By Ron Leuty
Staff Reporter, San Francisco Business Times
Jan 31, 2020, 3:04pm PST
Updated Jan 31, 2020, 3:15pm PST
Aimmune Therapeutics Inc. ended a nearly nine-year quest Friday by winning Food and Drug Administration for a first-of-its-kind peanut allergy treatment that protects people from potentially lethal accidental exposures.
The oral immunotherapy, a capsule of powderized peanut protein called Palforzia, is approved for kids ages 4-17 — a group whose parents kickstarted the Brisbane company's founding in 2011 after a venting meeting with clinicians, advocacy groups, regulators and drug developers.
"They were frustrated that there had been strides in other areas but not one in food allergy," Aimmune President and CEO Dr. Jayson Dallas told the Business Times earlier this month. "There was no clear and obvious regulatory pathway."
Aimmune (NASDAQ: AIMT) changed all of that, devising a way to create a biologic drug from food proteins, finding a method to consistently manufacture it and working with the FDA along a review process that took more than a year. Dosing of the drug is gradually increased over months to help the immune system acclimate to peanuts.
Palforzia will carry a wholesale acquisition cost of $890 per month, but Aimmune said it plans to offer patient co-pays that could reduce out-of-pocket costs to as low as $20 per month. The company also plans a patient assistance program that would provide the drug at no cost for eligible patients who do not have insurance coverage.
Aimmune's stock, which closed down 93 cents Friday to $31.05 per share, was up nearly 20% in after-hours trading to $37.03.
"This is a defining moment for the peanut allergy community and for Aimmune Therapeutics, and we are excited to bring the first FDA-approved treatment for peanut allergy to patients and their families," Dallas said in a statement.
Palforzia's approval doesn't mean those with peanut allergy can down dozens of peanuts — it should be used in conjunction with a peanut-avoidance diet, the company said — but in clinical trials some patients were able to tolerate exposure to the nuts.
Peanut allergy is one of the most common food allergies in the world, affecting more than 1.6 million children and teens in the United States alone. It has long been treated by allergy doctors by building up exposure to the allergen that perturbs the immune system and forces a reaction.
But there has not been a single drug available to patients on a widespread basis, and accidental exposures — from food cooked with peanut oil at a restaurant, for example — is a constant worry for patients and parents. Those exposures can be treated with an epinephrine pen, but coming in contact with peanuts can send those with the allergy into anaphylactic shock, which can be deadly.
Palforzia does come with caveats, namely side effects in the gut and potential complications for asthma patients. The drug also can cause anaphylaxis, the company said, and is available only through a restricted program
