French drug major Sanofi (SNYNF,SNY) announced Monday positive results of Dupixent (dupilumab) Phase 3 trial in chronic obstructive pulmonary disease or COPD.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
According to Sanofi, the latest results confirm potential to become first approved biologic for this serious disease.<\/p>\n
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.<\/p>\n
The company noted that Dupixent also rapidly and significantly improved lung function compared to placebo at 12 weeks and were sustained at 52 weeks. <\/p>\n
The FDA granted Breakthrough Therapy designation for Dupixent earlier this year as an add-on maintenance treatment in adult patients with uncontrolled COPD.<\/p>\n
The European Medicines Agency is reviewing Sanofi and Regeneron’s application for Dupixent for the treatment of uncontrolled COPD with type 2 inflammation.<\/p>\n
Discussions with other regulator authorities around the world are ongoing.<\/p>\n
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.<\/p>\n
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