Sanofi

FDA grants Breakthrough Therapy designation to tolebrutinib for nrSPMS, based on HERCULES study results showing 31% delay in disability progression and double the confirmed disability improvement rate compared to placebo.

FDA grants Breakthrough Therapy designation to tolebrutinib for non-relapsing secondary progressive multiple sclerosis, based on HERCULES study results showing 31% delay in disability progression and double the confirmed disability improvement rate compared to placebo.

Study MET59 evaluated meningococcal antibody persistence 3–6 years after priming with MenACYW-TT or MCV4-CRM vaccines in adolescents, and immune response post-booster with MenACYW-TT. Results showed immune response persistence and robust booster response, supporting ACIP's recommended priming at 11–12 years and booster at 16 years.

Sanofi announced FDA granted Breakthrough Therapy designation to tolebrutinib for nrSPMS, based on HERCULES phase 3 study results. Tolebrutinib is the first brain-penetrant BTK inhibitor in MS with this designation, showing potential to delay disability progression. Sanofi is finalizing US regulatory submissions and preparing for EU, with PERSEUS phase 3 study ongoing for primary progressive MS.

FDA grants Breakthrough Therapy designation to tolebrutinib for non-relapsing secondary progressive multiple sclerosis (nrSPMS), based on HERCULES study results showing 31% delay in disability progression and double the confirmed disability improvement rate compared to placebo. Tolebrutinib is the first brain-penetrant BTK inhibitor for MS with this designation.

FDA grants Breakthrough Therapy designation to tolebrutinib for non-relapsing secondary progressive multiple sclerosis (nrSPMS), based on HERCULES phase 3 study results showing 31% delay in disability progression and double the rate of disability improvement compared to placebo. Liver enzyme elevations observed in some participants, but resolved without intervention. Regulatory submissions ongoing for US and EU. Tolebrutinib is under clinical investigation.

Digital twins, powered by AI, could speed up drug discovery by simulating diverse patient anatomies and physiological responses, enhancing device testing and reducing clinical trial costs.