Sanofi (EPA: SAN; NASDAQ: SNY), a leading French pharmaceutical company, has announced positive results from two Phase III clinical trials for its drug Dupixent (dupilumab), indicating its potential for two distinct indications. The first trial, ADEPT, concentrated on the treatment of the rare skin condition bullous pemphigoid (BP), while the second, LIBERTY-CUPID Study C, addressed itch and hives in patients with chronic spontaneous urticaria (CSU). Both trials are anticipated to pave the way for regulatory approval filings in the near future.
In the ADEPT trial, Dupixent achieved significant success, meeting the primary and all key secondary endpoints in treating moderate-to-severe BP. The drug demonstrated superior efficacy, with five times more patients on Dupixent experiencing sustained disease remission compared to those on placebo. These findings are expected to support global regulatory submissions, with the U.S. being the first on the list later this year.
Additionally, Dupixent demonstrated efficacy in the LIBERTY-CUPID Study C, where it met all primary and secondary endpoints for treating patients with uncontrolled, biologic-naïve CSU who were undergoing background therapy with antihistamines. Dupixent, which works by inhibiting the interleukin-4 (IL4) and interleukin-13 (IL13) pathways to modulate autoimmune diseases, has been previously approved in Japan for CSU. However, this trial provides the necessary data to support regulatory filings for this indication in other regions. Sanofi plans to initiate discussions with the U.S. FDA regarding approval filing requirements shortly.- Flcube.com
