Benzinga - by Vandana Singh, Benzinga Editor.
On Friday, the FDA extended the target action date of priority review of supplemental application seeking approval for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD), a lung disease that’s usually caused by smoking.
The revised target action date is September 27, 2024. The FDA accepted the application in February, with a target action date of June 27, 2024.
The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.
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The FDA had requested additional efficacy analyses on Dupixent’s efficacy in the BOREAS and NOTUS pivotal trials.
Based on the submission of these analyses earlier in May, the agency has determined that this additional information constituted a major amendment to the application and extended the target action date accordingly.
Dupixent is the flagship drug of Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceutical Inc (NASDAQ:REGN).
Concurrently, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the European Union as an add-on maintenance treatment in adults with uncontrolled COPD characterized by raised blood eosinophils.
The positive CHMP opinion is supported by data from the landmark BOREAS and NOTUS phase 3 studies, which evaluated the efficacy and safety of Dupixent in adults with uncontrolled COPD and evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL).
The primary endpoint was met in both studies, showing Dupixent reduced annualized moderate or severe acute COPD exacerbations by up to 34% compared to placebo.
Dupixent rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.
Additionally, Dupixent improved health-related quality of life at 52 weeks.
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Price Action: SNY shares were trading higher by 0.63% at $48.13 premarket at the last check on Friday.
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