FDA Approves Regeneron/Sanofi's Blockbuster Dupixent For Smoker's Lung Disease

On Friday, the FDA approved Regeneron Pharmaceuticals, Inc. REGN and Sanofi SA’s SNY Dupixent (dupilumab) as an add-on maintenance treatment of inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, generally known as “smoker’s lung.”

Dupixent is the first biologic medicine approved in the U.S. to treat these patients.  

Also Read: Sanofi, Regeneron Drug Dupixent Shows Successful Treatment Of Patients With Inflammatory Skin Disease.

The FDA approval is based on data from two Phase 3 trials (BOREAS and NOTUS) that evaluated the efficacy and safety of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy (nearly all on triple therapy).

• Patients who received Dupixent in BOREAS (n=468) and NOTUS (n=470) experienced the following outcomes, respectively, compared to placebo (BOREAS n=471; NOTUS n=465):
• The primary endpoint is a 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks.
• 74mL and 68mL numerically greater improvements in post-bronchodilator FEV1 from baseline at week 12 compared to placebo, sustained at 52 weeks. Statistically significant improvements of similar magnitude were observed in pre-bronchodilator FEV1 from baseline at 12 and 52 weeks, a key secondary endpoint.
• 51% response in a health-related quality of life measure in both trials compared to 43% and 47% with placebo at 52 weeks.

About half of COPD patients continue to experience exacerbations despite being on triple inhaled therapy.

In the U.S., approximately 300,000 people live with inadequately controlled COPD and an eosinophilic phenotype.

Patients with an eosinophilic phenotype contribute to a ~30% increase in exacerbations and an increased risk of COPD-related re-hospitalizations within a year.

Today, China’s National Medical Products Administration also approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease characterized by raised blood eosinophils.

The approval is based on BOREAS and NOTUS Phase 3 trial results.

Price Action: At last check Friday, REGN stock was up 2.86% at $1,069.75, and SNY stock was up 1.49% at $57.85.

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