Aimmune Therapeutics, Inc., a privately held biopharmaceutical company developing desensitization treatments for food allergies, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to AR101, the company’s lead investigational product, for oral immunotherapy of peanut-allergic children and adolescents 4-17 years of age.

Breakthrough Therapy Designation, an FDA program intended to facilitate and expedite development and review of new drugs and biologics for the treatment of a serious or life-threatening condition, requires preliminary clinical evidence that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints. Under the program, the FDA will work closely with Aimmune Therapeutics on the subsequent development of AR101, including providing guidance on generating evidence needed to support approval of the drug in an efficient manner. AR101 also received FDA Fast Track Designation in September 2014, prior to Phase 2 clinical data.

“We are very grateful for the FDA’s recognition of the large impact AR101 could have in reducing the incidence of life-threatening allergic reactions in people with peanut allergies,” said Stephen Dilly, M.B.B.S., Ph.D., Chief Executive Officer of Aimmune Therapeutics. “Currently, there are no approved medical therapies to treat the more than two million children and adolescents in the United States and Europe with peanut allergy who are vulnerable to reactions from accidental exposures. We are eager to continue working closely with the FDA and to receive its guidance to help make AR101 available to patients as soon as possible.”

For more details, go to: http://www.aimmune.com/aimmune-therapeutics-receives-fda-breakthrough-therapy-designation-for-ar101/