Sanofi announced on September 2, 2024 that its experimental multiple sclerosis drug tolebrutinib failed to meet the primary endpoint of two late-stage clinical trials.
September 2, 2024 • By Handicap.fr with AFP
Disappointment. On September 2, 2024, the French pharmaceutical group Sanofi indicated in a press release that the treatment studied did not demonstrate a significant difference compared to Aubagio, its drug currently marketed against multiple sclerosis (SEP), depending on the statistical criteria used.
Reduction of insufficient thrust rate
“The primary endpoint of the GEMINI 1 and 2 studies evaluating tolebrutinib in people with relapsing-remitting MS, which was a reduction in the annualized relapse rate, did not reach statistical significance compared to Aubagio (teriflunomide),” the statement said. Relapsing-remitting multiple sclerosis is the most common form of this autoimmune disease that affects the central nervous system and can progress to irreversible physical and cognitive disabilities over time.
Effective for another form of MS
Aubagio’s sales for multiple sclerosis have been hurt by generic competition since last year. In contrast, in another late-stage clinical trial that evaluated the efficacy and safety of tolebrutinib in participants with non-active secondary progressive MS, tolebrutinib “met the primary endpoint and extended the time to confirmed disability progression”compared to placebo. There are currently no approved treatments for these patients with MS.
Greatest unmet medical need
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