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On Wednesday, the European Medicines Agency (EMA) approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.
Specifically, the approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA) or on a combination of LABA and LAMA if ICS is not appropriate.
Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) are jointly developing dupilumab under a global collaboration agreement.
The EMA is the first regulatory authority in the world to approve Dupixent for COPD patients.
Read Next: Regeneron’s Dupixent COPD Sales To Reach $20B By 2026, Analyst Sees Larger Addressable Market.
Dupixent is the first new treatment approach for COPD in more than a decade and a new option for approximately 220,000 adults in the EU.
The approval represents the sixth approved indication for Dupixent in the EU and the seventh approved indication globally.
The approval is based on results from the landmark phase 3 BOREAS and NOTUS studies.
In terms of efficacy, Dupixent patients in BOREAS (n=468) and NOTUS (n=470) experienced the following, respectively, compared to placebo (BOREAS n=471; NOTUS n=465):
30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks-the primary endpoint.
Improvements in lung function (pre-bronchodilator FEV1) from baseline by 160 mL and 139 mL at 12 weeks compared to 77 mL and 57 mL.
These improvements were observed as early as weeks 2 and 4 and were sustained at 52 weeks in both studies.
Improvements in health-related quality of life (statistically significant in BOREAS and nominally significant in NOTUS)
Reductions in exacerbations and improved lung function for Dupixent versus placebo were also observed in patients with higher baseline fractional exhaled nitric oxide (≥20ppb) – an airway biomarker of inflammation.
In May, 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 COPD, a lung disease that’s usually caused by smoking, with a target action date of September 27.
The FDA requested additional efficacy analyses on Dupixent’s efficacy in the BOREAS and NOTUS pivotal trials.
Price Action: REGN shares were trading higher by 0.16% at $1,046.28 premarket session at last check Wednesday. SNY shares were up 0.31% at $48.69.
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