Aimmune says FDA review of BLA delayed by government shutdown

In a regulatory filing, Therapeutics announced that it has been notified by the U.S. Food and Drug Administration that as a result of the U.S. government shutdown and lapse in appropriations, the FDA will not commence review of the company’s Biologics License Application, or “BLA,” for AR101, the company’s investigational biologic oral immunotherapy for the treatment of peanut allergy in children and adolescents ages 4-17. “The FDA indicated that it will initiate review of the BLA when the U.S. government shutdown and lapse in appropriations has ended. As previously announced, the company submitted its BLA for AR101 on December 21, 2018, prior to the U.S. government shutdown,” Aimmune stated.

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