Regeneron and Sanofi will have to wait until September 2024 for the FDA to decide whether to expand Dupixent’s label to include uncontrolled chronic obstructive pulmonary disease.
Regeneron announced Friday that the FDA has delayed its priority review of a supplemental BLA for Dupixent in uncontrolled chronic obstructive pulmonary disease, as the monoclonal antibody nears European Union approval.
The FDA has extended the target action date for its priority review by three months, with the PDUFA set for Sept. 27, 2024. While the regulator did not raise any concerns about the “approvability” of Sanofi-partnered Dupixent in uncontrolled chronic obstructive pulmonary disease (COPD), Regeneron said the agency has requested additional analyses on the drug’s efficacy in the Phase III Boreas and Notus trials.
Regeneron said that the FDA has determined that this additional information “constituted a major amendment” to the sBLA and, therefore, and necessitated extending the timeline to make its decision. The original date with the FDA was set for June 27, 2024.
In a note to investors, Bank of Montreal Capital Markets analysts said that delays in the COPD approval will likely be a “limited drag” to Regeneron’s shares.
“We highlight that this delay in approval timelines is not a reflection on Dupixent’s efficacy in COPD, and we remain highly confident in approval given the strength of data demonstrated in both Boreas and the Notus trials,” the analysts wrote.
Regeneron on Friday also announced it received positive news from European regulators. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given Dupixent a favorable opinion and recommends the drug’s use as an add-on treatment in adults with uncontrolled COPD. The European Commission will make a final decision sometime in the coming months.
CHMP’s positive opinion was based on the data in the Boreas and Notus Phase III trials. In March 2023 , the Boreas trial reached all primary and secondary endpoints and showed a reduction in moderate or severe episodes of COPD exacerbations. In the trial, Dupixent use led to a 30% drop in moderate or severe acute COPD exacerbations across 52 weeks of treatment.
The Notus trial, which reported its results in May 2024, investigated Dupixent’s use as an add-on maintenance treatment and demonstrated that it can also reduce exacerbations in patients with COPD. The trial showed that the drug cut exacerbations by 34% over 52 weeks and earned a p-value of 0.001.
Dupixent has been a solid earner for Regeneron and Sanofi. In the first quarter of 2024, sales generated $3.08 billion, short of analyst expectations but still a 24% increase from Q1 2023.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
