The pivotal Phase 3 Libery ASthma Quest study of dupilumab in a broad population of patients with uncontrolled, persistent asthma met its two primary endpoints, Sanofi and Regeneron Pharmaceuticals said Monday.
According to the study, dupilumab, when added to standard therapies, reduced severe asthma attacks (exacerbations) and improved lung function.
The companies said they plan to submit a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) by the end of this year.
George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron, pointed out that about one million U.S. adults and adolescents live with uncontrolled, persistent asthma, and continue to experience serious asthma attacks, despite taking an intensive regimen of standard therapies. “Dupilumab has now demonstrated positive late-stage results in two serious allergic diseases — asthma and atopic dermatitis — with robust efficacy and an extensive safety database. These results continue to support our hypothesis that the IL4/IL13 pathway is a critical driver of allergic disease, and weremain committed to further investigating the IL-4/IL-13 pathway in other allergic diseases,” he said.
Elias Zerhouni, M.D., President, Global R&D, Sanofi, said that therapies like dupilumab, which focus on specific molecular pathways such as the Th2 pathway associated with multiple chronic allergic diseases, are important targets for further investigation. Zerhouni said that the positive data from this large second pivotal trial, after the positive results of dupilumab in atopic dermatitis, further support the result.
A logo is seen in front of the entrance at the headquarters French drugmaker Sanofi in Paris October 30, 2014. REUTERS/Christian Hartmann/File Photo