05:00 AM EDT, 09/22/2025 (MT Newswires) -- Sanofi ( SNY ) said Monday the US Food and Drug Administration has extended the target action date of its review of the new drug application of tolebrutinib to treat non-relapsing, secondary progressive multiple sclerosis by three months.

The FDA determined that the additional information constituted a "major amendment" to the application, based on the submission of further analyses during the review, the company said.

The new target action date for the FDA decision is Dec. 28, Sanofi ( SNY ) said.

Multiple sclerosis is a neurodegenerative disease of the central nervous system that may lead to accumulation of irreversible disabilities over time.