Sanofi's Tolebrutinib Gets FDA Breakthrough Therapy Designation For NrSPMS

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(RTTNews) - French drug major Sanofi (SNY) announced Friday that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive multiple sclerosis or nrSPMS.

Tolebrutinib is the first and only brain-penetrant BTK inhibitor in MS to be designated Breakthrough Therapy by the regulator.

The FDA decision was based on positive results from the HERCULES phase 3 study, which showed that tolebrutinib delayed the time to onset of 6-month confirmed disability progression or CDP, by 31% compared to placebo. Further analysis of secondary endpoints demonstrated that the number of participants who experienced confirmed disability improvement was nearly double with tolebrutinib compared to those on placebo.

FDA's Breakthrough Therapy designation is given to expedite the development and review of medicines in the US that target serious or life-threatening conditions.

Erik Wallstrm, Global Head of Neurology Development, Sanofi, said, "This Breakthrough Therapy designation demonstrates the potential for tolebrutinib to delay disability progression, a critical unmet need for people living with multiple sclerosis. We look forward to working with the FDA during the regulatory review of this first of its kind medicine in non-relapsing secondary progressive multiple sclerosis where there are currently no approved treatments available."

The company noted that it is finalizing regulatory submissions of tolebrutinib for the US and preparing for the EU. As with other medicines, Sanofi plans to confirm once a regulatory submission for tolebrutinib has been accepted.

The PERSEUS phase 3 study in primary progressive MS is currently ongoing with study results anticipated in H2 2025.

Tolebrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

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