FDA delays review of peanut allergy drug amid Trump shutdown
One of the first pharma victims of the current partial shutdown of the US government has emerged after the FDA said it would delay a review of a peanut allergy drug from Aimmune Therapeutics.
In a filing with the Securities and Exchanges Commission, California-based Aimmune said that it had received notification that the FDA will not begin reviewing AR101 until the shutdown had ended.
Large sections of the US federal government are currently shut down or have cut back operations because of the ongoing row over president Donald Trump’s border wall with Mexico.
Trump needs backing of Congress to approve the $5.7 billion he needs to fund the wall, which is included in a large raft of spending plans.
But the opposition Democratic party is in control of the House of Representatives, and is refusing to sign off the plans, meaning there is no new money to run government agencies until the situation is resolved.
The FDA has reserves of cash from user fees paid by pharma companies for reviews that has allowed it to carry on with tasks it considers to be a priority.
But the FDA has said it will not accept new filings until funding has been resumed, with Aimmune being one of the first affected.
According to Aimmune the FDA has said it will begin its review of the filing for the treatment of children with peanut allergies aged 4-7 when the US government shutdown has ended.
Aimmune submitted the dossier for AR101 on December 21, the day before the US government shutdown began.
The biotech is hoping that data from the phase 3 PALISADE trial, which concluded last year, will convince the FDA to approve what could be the first ever drug to protect peanut allergy sufferers from potentially deadly allergic reactions.
AR101 is a biologic drug that aims to build tolerance by providing a controlled dose of peanut protein.
An intent-to-treat analysis at the end of the trial showed 76.6% of 372 patients in the treatment arm could tolerate 300 mg of peanut protein, 67.2% could tolerate 600 mg, and 50.3% could tolerate 1,000 mg, and results were highly statistically significant compared with placebo.
