Aimmune’s Peanut Allergy Treatment Delayed as Government Shutdown Continues

The partial government shutdown has entered day 24 and the pharma and medtech industry is beginning to feel the impact even more, particularly as the U.S. Food and Drug Administration (FDA) grows more incapable of reviewing some medications for approval. On Monday, California-based Aimmune Therapeutics announced that its anticipated peanut allergy drug AR101 is one of those drugs that the FDA cannot review for regulatory approval. In a filing with the U.S. Securities and Exchange Commission, Aimmune said it was notified by the FDA that due to the partial shutdown, the regulatory agency cannot begin to review the company’s Biologics License Application for AR101, which was filed Dec. 21, 2018, prior to the U.S. government shutdown. The FDA indicated that it will initiate a review of the BLA when the U.S. government shutdown and lapse in appropriations has ended, Aimmune said in its filing.
The company had been hoping the FDA could position AR101 for potential approval, particularly after positive Phase III data that showed its peanut allergy therapy was effective in more than 67 percent of juvenile patients. Aimmune’s AR101 is an oral biologic desensitization therapy that is sprinkled over food before eating.