Sanofi and Regeneron's Dupixent meets endpoints in clinical trial
March 23 (Reuters) - Healthcare firms Sanofi and Regeneron said their Dupixent product, which treats the skin disease atopic dermatitis, has met primary and all secondary endpoints in a trial to treat chronic obstructive pulmonary disease (COPD).
Dupixent showed a 30% reduction in moderate or severe acute exacerbations of COPD, a respiratory disease that damages the lungs and causes progressive lung function decline, in the Phase 3 trial, while also showing improvements in lung function, quality of life and COPD respiratory symptoms, the companies said on Thursday.
"The safety results were generally consistent with the known safety profile of Dupixent in its approved indications," the companies said, adding that efficacy and safety results would be presented later.
The trial, first of two phase 3 trials, included 939 adults who were current or former smokers aged between 40 years and 80 years and were randomized to receive Dupixent or a placebo.
Overall rates of adverse events were 77% for Dupixent and 76% for placebo.
The companies on Tuesday announced that the European Commission (EC) had approved Dupixent in the European Union to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy.
Dupixent was also approved by the EC to treat eosinophilic esophagitis, which is a condition that damages the esophagus, in January.
(Reporting by Juby Babu in Bengaluru; Editing by Rashmi Aich)