Regeneron says FDA requested additional analyses during Dupixent sBLA review

In a regulatory filing, Regeneron disclosed that in April 2024, during its review of the company’s sBLA for Dupixent in COPD with type 2 inflammatory phenotype, which has a target action date of June 27, 2024, the FDA requested that the company provide additional analyses regarding sub-populations from the BOREAS and NOTUS pivotal studies by the end of May 2024. “While we anticipate providing these additional analyses to the FDA substantially sooner, if the FDA determines that these analyses constitute a major amendment of the sBLA, the FDA’s review of the sBLA would be extended by up to three months pursuant to the applicable regulations,” the company stated in its 10-Q report.