Sanofi announced that the European Commission has approved Cenrifki (tolebrutinib), marking a historic milestone as the first and only therapy authorized in the European Union specifically to target disability progression in adults with non-relapsing secondary progressive multiple sclerosis (nr-SPMS).
Until now, patients living with nr-SPMS faced a critical unmet medical need, with no approved therapeutic options available to directly combat accumulation of disability in the absence of clinical relapses. Cenrifki works by actively addressing the underlying biological drivers of progression within the central nervous system.
The approval is supported by robust data from the phase 3 clinical development program, which demonstrated a significant delay in the time to confirmed disability progression. This milestone reinforces Sanofi’s long-standing dedication to pioneering scientific breakthroughs and transforming patient care standards within neurology.
With this regulatory authorization, Sanofi plans to make Cenrifki available to eligible healthcare systems and patients across Europe as quickly as possible, offering a foundational shift in how this challenging form of multiple sclerosis is managed.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
