Aimmune Therapeutics Receives FDA Breakthrough Therapy Designation for AR101

Industry News

Aimmune Therapeutics, formerly known as Allergen Research Corporation (ARC) that is based in Brisbane, CA, announced that it has received Breakthrough Therapy Designation  from the U.S. FDA for its peanut-allergy therapeutic, AR101.  Food allergies are a significant and growing health problem affecting an estimated 5% of children and 4% of adults in the US, and peanut allergy is one of the most common food allergies.  For people living with peanut allergy, peanuts can cause severe allergic reactions, including potentially life-threatening anaphylaxis.  Currently, there are no approved drugs to cure peanut allergy or prevent the consequent effects.  Therefore, people with peanut allergy are advised to avoid peanut and peanut products and carry epinephrine auto-injectors for use in case of accidental exposure.  AR101 is an oral immunotherapy designed to desensitize patients with peanut allergy.  It is a complex mixture of naturally occurring proteins and pharmaceutical-grade inactive ingredients with well-defined concentrations of peanut allergens aimed at desensitization through gradual dose escalation.  A recently completed Phase II study with AR101 has shown promising positive results and the company is planning to initiate a Phase III trial soon.


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