Sanofi Posts Positive NOTUS Trial Result Of Dupixent In COPD

(RTTNews) - French drug major Sanofi (SNYNF, SNY) announced Monday positive results of Dupixent (dupilumab) Phase 3 trial in chronic obstructive pulmonary disease or COPD.

In the second Dupixent investigational Phase 3 trial - NOTUS, Dupixent significantly reduced COPD exacerbations. The company noted that Supplemental BLA submission to the U.S. Food and Drug Administration is planned by end of 2023.

Sanofi and Regeneron plan to submit the data from this replicate trial, along with positive results from the Phase 3 BOREAS trial, to the FDA by the end of the year.

NOTUS and BOREAS are replicate, randomized, Phase 3, double-blind, placebo-controlled trials that evaluated the efficacy and safety of Dupixent in adults who were current or former smokers with moderate-to-severe COPD.

According to Sanofi, the latest results confirm potential to become first approved biologic for this serious disease.

NOTUS trial met its primary endpoint with overwhelming efficacy, showing Dupixent significantly reduced exacerbations by 34% compared to placebo in patients with moderate-to-severe COPD with evidence of type 2 inflammation. This confirms results from the landmark BOREAS pivotal trial.

The company noted that Dupixent also rapidly and significantly improved lung function compared to placebo at 12 weeks and were sustained at 52 weeks.

The FDA granted Breakthrough Therapy designation for Dupixent earlier this year as an add-on maintenance treatment in adult patients with uncontrolled COPD.

The European Medicines Agency is reviewing Sanofi and Regeneron's application for Dupixent for the treatment of uncontrolled COPD with type 2 inflammation.

Discussions with other regulator authorities around the world are ongoing.

Sanofi added that the safety and efficacy of Dupixent in COPD are currently under clinical investigation and have not been evaluated by any regulatory authority.

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