Sanofi has announced a significant delay in the U.S. regulatory decision for its experimental multiple sclerosis drug, tolebrutinib, which is now expected to extend beyond the original action date of December 28. This marks a second postponement, following an initial expectation for a September decision, and comes on the heels of disappointing late-stage study results. Analysts suggest that these setbacks could diminish confidence in Sanofi’s drug pipeline, especially after earlier reported failures in its eczema and smoker’s lung treatments. The company faces increasing pressure to diversify its portfolio beyond its successful asthma drug, Dupixent.
In contrast, the FDA has granted approval for Zoliflodacin, a novel oral antibiotic aimed at treating gonorrhea, marking a significant advancement in the fight against this sexually transmitted infection. This approval is particularly noteworthy as it represents the first new drug specifically targeting Neisseria gonorrhoeae in decades, addressing the growing issue of antibiotic resistance. Developed through a public-private partnership between Innoviva and the Global Antibiotic Research and Development Partnership (GARDP), Zoliflodacin, marketed as Nuzolvence, could reshape treatment protocols for gonorrhea, which has increasingly seen failures with existing therapies. This juxtaposition of Sanofi’s challenges and the FDA’s proactive measures highlights the dynamic nature of the pharmaceutical landscape.
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