预约演示

On a roll, Sanofi and Regeneron's Dupixent scores again in second COPD trial

2023-11-27

临床3期临床结果突破性疗法上市批准优先审批

Roughly 300,000 people in the United States have the potentially fatal lung condition COPD with type 2 inflammation. By acing a second phase 3 trial, Regeneron and Sanofi's Dupixent is set up to become the first biologic to treat the condition.

Sanofi and Regeneron’s Dupixent has scored in a second phase 3 study in chronic obstruCOPDe pulmtype 2 inflammation), setting up the monoclonal antiboRegeneronome tSanofist Dupixent to treat the lung disease and the first advancement in the indication in more than a decade.

SanofirovalRegeneronwouDupixentDupixent to another huge market. As a trechronic obstructive pulmonary disease (COPD)eral other inflammatory conditions, Dupixent already is on a juggernaut trajectlung diseasein $3.1 billion in the third quarter, which was a 33% increase year over year. The third-quarter haul brought the drug's sales for the first nine months to $8.4 billion.

Results from thCOPDTUS study shDupixentt patients on Dupixent, compared to those onasthmaboatopic dermatitis4% reduction in COPD exacerbations that needDupixentional treatment. The treatment also produced significant lung function improvement within 12 weeks, which sustained through 52 weeks.

“These results were from an interim analysis and, givDupixentverwhelmingly positive efficacy of the primary endpoint, will bCOPDnsidered the primary analysis of the trial,” Sanofi and Regeneron said in a release.

The companies plan to submit the data, along with results from the phase 3 BOREAS trial, to the FDA by the end of this year.Sanofi Regeneron

Results from BOREAS were presented earlier this year, showing a 30% reduction in exacerbations. FDA study included 939 COPD patients with type 2 inflammation who were active or former smokers on maximal standard-of-care inhaled therapy and achieved its primary and secondary objectives. The FDA granted breakthrough therapy designation for Dupixent in COPD based on data from the trial.

The European Medicines Agency already is reviewing Dupixent as a treatment for patients with uncontrolled COPD with typCOPDinflammation. Itype 2 inflammation, there are approximately 300,000 people with COPD and type 2 inflammation.FDA Dupixent COPD

SanoEuropean Medicines Agencystigating another COPDDupixentte, itepekimab, for former smokers, which make COPDoughlytype 2 inflammation population. Itepekimab is due for a readout in 2025, according to NCOPDsh Patype 2 inflammation head of global development, immunology and inflammation. The drug is an IL-33 inhibitor, while Dupixent inhibits the IL-4 and IL-13 pathways.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构