As we reported in late December, Aimmune submitted their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for AR101, an investigational biologic oral immunotherapy for the treatment of peanut allergy in children and adolescents ages 4–17.
Submission of a BLA is the last step in obtaining permission to market a drug after successful clinical trials.
However, Monday we learned there will be delays: the company filed a Form 8-K with the Securities and Exchange Commission reporting that the FDA has shelved consideration of the drug until the government shutdown is over and funding is restored.
Here is the critical portion of the filing:
Aimmune Therapeutics, Inc. (the “Company”) announced that it has been notified by the U.S. Food and Drug Administration (the “FDA”) 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 (“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.
Approval of many other drugs will similarly be delayed.