Sanofi reports that the US FDA has granted priority review to its regulatory application for tolebrutinib for the treatment of multiple sclerosis (MS) in adults. The authority is expected to issue its decision on 28 September.
If approved, tolebrutinib will be the first and only brain-penetrant BTK inhibitor for the treatment of relapse-free, secondary-progressive MS and the slowing of disability accumulation, irrespective of relapse activity.
Tolebrutinib has been granted 'breakthrough drug' designation by the FDA, based on positive results from the HERCULES Phase III study. A marketing authorisation application is also under review by EU regulatory authorities.
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