Sanofi/Regeneron's Blockbuster Prescription Drug Dupixent Shows Additional Promise In Chronic Lung Disorder

Regeneron Pharmaceuticals Inc REGN and Sanofi SA SNY announced the second Dupixent (dupilumab) Phase 3 chronic obstructive pulmonary disease (COPD) trial (NOTUS) showed that Dupixent significantly reduced exacerbations.

The European Medicines Agency is reviewing the Dupixent application for uncontrolled COPD with type 2 inflammation; this application is based on results from the BOREAS trial. 

Regeneron and Sanofi plan to submit the data from this replicate trial and results from the Phase 3 BOREAS trial to the FDA by the end of the year.

The NOTUS trial also confirmed that treatment with Dupixent led to rapid and significant improvements in lung function by 12 weeks and was sustained at 52 weeks.

Also Read: Regeneron Pharmaceuticals Stock Upgraded After Q3, But There Is A Headwind - Analyst Review.

The trial evaluated the investigational use of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled COPD and evidence of type 2 inflammation. 

The companies said that the results were from an interim analysis and, given the efficacy of the primary endpoint, it will be considered the trial's primary analysis. 

The NOTUS trial included 935 adults who were current or former smokers aged 40 to 85 years. Patients receiving Dupixent compared to placebo experienced:

• 34% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0002), the primary endpoint.
• Improved lung function from baseline by 139 mL at 12 weeks compared to 57 mL for placebo (p=0.0001), with the benefit versus placebo sustained at week 52 (115 mL for Dupixent versus 54 mL for placebo, p=0.0182).

In October, Sanofi announced its plans to spin off its consumer healthcare business to increase its focus on innovative medicines and vaccines.

Price Action: REGN shares closed at $798.30 on Friday, and SNY stock is up 0.89% at $47.60 during the premarket session on the last check Monday.