Press Release: Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis

Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS)Tolebrutinib is the first and only brain-penetrant BTK inhibitor in MS to be designated Breakthrough Therapy by the FDA  Paris, December 13, 2024. The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for ...