Sanofi: Dupixent SBLA Accepted For FDA Priority Review For COPD With Type 2 Inflammation

(RTTNews) - French drug major Sanofi (SNYNF, SNY) announced Friday that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application or sBLA for Dupixent (dupilumab).

The sBLA is for Dupixent in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease or COPD.

The target action date for the FDA decision is June 27, 2024. The company noted that regulatory submissions are also under review in China and the European Union.

If approved, Dupixent would be the only biologic therapy for COPD and the first new treatment approach for the disease in more than a decade, Sanofi said.

COPD is a respiratory disease that damages the lungs and causes progressive lung function decline, with symptoms including persistent cough, breathlessness and excessive mucus production.

The company said the Priority Review is granted based on positive results from two Phase 3 trials.

The sBLA, along with other worldwide submissions, are supported by data from the Phase 3 COPD clinical research program evaluating the efficacy and safety of Dupixent in adults who were current or former smokers with uncontrolled COPD with evidence of type 2 inflammation.

The primary endpoint was met in both trials of BOREAS and NOTUS, showing Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30% and 34% respectively, compared to placebo.

In both trials, Dupixent also rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.

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