The FDA has delayed its decision about Sanofi’s oral multiple sclerosis drug, tolebrutinib, extending the target action date of the review of the NDA by three months.
Originally, the FDA had accepted tolebrutinib for priority review with a decision date of September 28. The FDA has since determined that additional analyses during the review require a major amendment to the NDA and has subsequently changed the target action date to December 28.
Tolebrutinib is an oral and brain-penetrant investigational Bruton’s tyrosine kinase (BTK) inhibitor. It is indicated in treatment of adults with non-relapsing, secondary progressive multiple sclerosis (nrSPMS). The drug slows disability accumulation independent of relapse activity.