The Food and Drug Administration (FDA) agreed to expedite the review of a specially formulated peanut product. The peanut product, called AR101, is being studied as a potential allergy treatment.
The status was granted after the company released positive results of recent clinical trials. The designation means that the FDA will work closely with the company to speed the development and review of the product.
AR101 is made by AimmuneTherapeutics, Inc. Aimmune Therapeutics is a biopharmaceutical company developing desensitization treatments for food allergies.
The company is getting ready to study AR101 in a Phase III clinical trial. The results of Phase III trials ultimately determine whether a product is approved for sale.
The company recently released positive results of the product in a European allergy meeting. The study showed that all 23 patients using the peanut product in oral immunotherapy were able to tolerate at least 443 mg of peanut protein. A majority of patients (78%) were able to tolerate even great amounts of peanut protein - 1,043 mg.
In oral immunotherapy, research patients eat a tiny dose of the food they are allergic to. The patients gradually increase this amount over a short period of time until they reach a target dose amount. This is usually maintained every day.
It is not known how “permanent” the effect of this treatment may be once the daily ingestion is stopped. It also is not known how long patients have to ingest the treatment, or what the long-term effects are.
This is the second time this year the FDA has granted this special review status to a potential food allergy treatment. In April, the peanut skin patch called Viaskin was also granted the special status. Viaskin is another form of immunotherapy, but the food proteins are delivered through the skin instead of the mouth.
DBV Technologies, which makes Viaskin, recently won approval to begin Phase III trials by the end of 2015.