The FDA is now officially reviewing the biologics license application (BLA) for AR101, the peanut oral immunotherapy drug that underwent successful clinical trials.
“The FDA’s acceptance of our BLA is a crucial step forward in delivering AR101 to children, teens and families living with the serious, daily risk of allergic reactions to accidental exposure to peanuts,” Dr. Jayson Dallas, president and CEO of Aimmune Therapeutics, the company developing the OIT therapy, said in a press release. The company is seeking to have the oral immunotherapy drug approved for use in patients between the ages of 4 and 17.
The FDA says the review may take 12 months, and backdates the license application to January, when it was submitted but then held up because of the U.S. government shutdown. The evaluation is to be complete by January 2020, if not earlier.
“We are working with the FDA to complete their review as expeditiously as possible given that there are currently no approved medicines for peanut allergy,” Dallas added. (Last year, Aimmune had hoped to have this license approval by the fall.)
The AR101 therapy is designed to help a peanut-allergic patient become desensitized (as opposed to cured) and protected in case of accidental exposures to peanut in foods. In the treatment, a patient consumes minute, then larger peanut doses, until a maintenance dose for daily consumption is reached. The idea behind AR101 is to create a highly standardized drug and protocol – to make it possible for any allergist to offer.
In exit challenges from the trial called Palisade, half of those being treated with the AR101 biologic could consume a dose of 1,000 mg (about three to four peanut kernels) with no symptoms or very mild symptoms. The median amount of peanut that participants could tolerate at the start of the study was only 10 mg.
The FDA granted the drug “breakthrough status” back in 2015, and the New England Journal of Medicine published the positive final results of the trials investigating the AR101 last November.
Aimmune’s chief medical officer, Dr. Daniel Adelman makes the case that allergen avoidance isn’t always enough. He contends: “There is an urgent need for a rigorously developed, clinically proven medicine like AR101 that can help protect people when accidental exposures do occur.”