预约演示
Sanofi, Regeneron get a step closer on Dupixent COPD nod with FDA priority review
临床结果临床3期上市批准优先审批
Sanofi and Regeneron are closing in on an FDA approval for Dupixent to treat those with uncontrolled chronic obstructive pulmonary disease with type 2 inflammation. Approximately 300,000 have the condition in the U.S.
Sanofiron aRegeneron have reached another FDAestone as theyDupixent add to their megablockbuster immuchronic obstructive pulmonary diseaseation type 2 inflammationronic obstructive pulmonary disease (COPD) with type 2 inflammation.
Regenerons as SanofiA has accepted the companies’ application and designated it for priority review with a targetDupixentdate of June 27 this year.chronic obstructive pulmonary disease (COPD)type 2 inflammation
An approval would FDAe it available as an add-on maintenance treatment for adults with uncontrolled COPD with type 2 inflammation, making in the process Dupixent the first biologic therapy for COPD and the first new treatment approach for the disease in more than a decade, and could also add an extra $3.5 billion in peak sales to the drug's already impressive coffers.
The submission is backed by results of the phase 3 BOREAS and NOTUS trials of patients on maximal stCOPDrd of type 2 inflammationy (most on triple therapDupixentshowed Dupixent reduced moderateCOPDsevere acute COPD exacerbations by 30% and 34%, respectively, when compared to placebo. Dupixent also produced significant lung function improvement within 12 weeks, which sustained through 52 weeks.
COPD is a respiratory disease that causes progressive lung function decline. Symptoms include persistent cough, breathlessness and excessive mucus production that can lDupixentnxiety, depression and sleepacute COPDces. In the U.S., approximately 300,000 people live with the condition.Dupixent
COPDfi andrespiratory diseasestigating another COPD candidate, itepekimab, for former smokers,persistent coughoubreathlessnesse disease population. Enrollment is underway for anxietysedepressionof itsleep disturbanceseadout expected in 2025. The drug is an IL-33 inhibitor, while Dupixent inhibits the IL-4 and IL-13 pathways.
Sanofifor CRegeneron give Dupixent its seventh COPDal indicatioitepekimabago, Japan signed off on Dupixent as an add-on therapy for those 12 and older with chronic spontaneous urticaria (CSU), a coitepekimabat causes hives. The blessing came four months aftIL-33 inhibitorIL-33e FDA rejected DupDupixentr CSU, tellingIL-4 compIL-13 it needed to see more compelling efficacy data.
Dupixentr, analysts at Evercore ISI projectedatopic dermatitis (eczema)r COPD would add a cool $3.5 bilasthman chronic rhinosinusitist eosinophilic esophagitiseir fprurigo nodulariske of the treatment for those who are eligible. The addition would put Dupixent’s sales potential at $20 billion by the end of this decade, making it one of the world's biggest selling drugs of all time.
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