Sanofi: Innovative drug designation for SPMS
(CercleFinance.com) - Sanofi announces that tolebrutinib has received Breakthrough Therapy designation from the US FDA for the treatment of relapse-free, secondary-progressive multiple sclerosis (SPMS) in adults.
This designation was prompted by the positive results of the HERCULES Phase III study, which showed that tolebrutinib reduced the time to confirmed disability progression by 31% compared to placebo.
In the US, 'innovative drug' designation is intended to accelerate the development and review of drugs for the treatment of serious or life-threatening diseases, the healthcare group said.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
This designation was prompted by the positive results of the HERCULES Phase III study, which showed that tolebrutinib reduced the time to confirmed disability progression by 31% compared to placebo.
In the US, 'innovative drug' designation is intended to accelerate the development and review of drugs for the treatment of serious or life-threatening diseases, the healthcare group said.
Copyright (c) 2024 CercleFinance.com. All rights reserved.