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 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.

Aimmune is certainly not the only company that is experiencing shutdown woes as its product is delayed getting to market. On Monday, FDA Commissioner Scott Gottlieb issued a series of Twitter explanations for the state of regulatory approval during the shutdown. Gottlieb noted that drugs submitted for approval that are covered by the user fee program can be reviewed during the shutdown. The fees paid as part of that program can cover the costs, he said. But, Gottlieb noted that products not covered by the user fee program, which includes blood and allergenic extracts like AR101, cannot be reviewed while the shutdown continues.

“These product categories are not associated with a user fee program. As a result, during the lapse, FDA activities for products are limited to emergency work involving safety of human life, such as monitoring for adverse events and, if warranted, taking action to protect patients,” Gottlieb said on Twitter.

With a lack of additional funding, the FDA has suspended reviews of existing Investigational New Drug (IND) and Biologics License Application (BLA) applications not covered by user fees. Under the Prescription Drug User Fee Act ranged between $1.5 million to $2.7 million.

The FDA has been using its collected fees to continue reviewing some drugs. STAT News noted that last week the regulatory agency used the fees to hold an advisory panel regarding Takeda Pharmaceuticals’ gout drug Uloric. Those funds are not expected to last too long though if the shutdown continues. The FDA has noted its reserves of fees can last for a few more weeks, but there are a number of companies anticipating potential approval of their products. If the shutdown continues, those potential approvals will be delayed.   

While Aimmune announced that its BLA review will be delayed, several other companies have said they have not received word. According to STAT, Janssen, Novartis and Sanofi, all of which are expecting potential FDA approval by March, have not yet been notified about whether or not there will be a delay.

It’s not only the potential approval of a new drug that the funding is impacting. There are also meetings scheduled between companies and the regulatory agency to discuss clinical plans for the development of drugs. Those have also been delayed, or will likely be delayed unless the government re-opens soon.