Sanofi’s drug Tolebrutinib delays progressive MS by 31% in study

By Ludwig Burger

FRANKFURT (Reuters) – Sanofi said on Friday that its drug candidate for multiple sclerosis could delay the worsening of a progressive form of the disease by 31 percent. The French pharmaceutical company is now considering applying for approval for the drug this year.

The company said in a brief summary earlier this month that the advanced trial of its drug candidate tolebrutinib had been successful, mitigating a setback that emerged at the same time that trials on a more common, relapsing form of the disease had failed.

Sanofi is pursuing several options in the field of MS, a debilitating nerve disease, to offset sales losses following the recent expiration of patent protection for its MS drug Aubagio and is part of its efforts to become a leading provider of anti-inflammatory drugs.

CEO Paul Hudson has made progress in restoring investor confidence in the pharmaceutical pipeline since he surprisingly abandoned 2025 margin targets last October to increase drug development spending.

Tolebrutinib, from the $3.7 billion acquisition of Principia in 2020, belongs to a class of compounds known as Bruton's tyrosine kinase (BTK) inhibitors, which have also attracted Novartis and Roche.

They are designed to selectively block the harmful autoimmune response underlying MS, allowing a more targeted approach than conventional immunosuppressants.

However, investors are concerned about the sales outlook because BTK inhibitors may cause liver damage and their effectiveness is uncertain.

Sanofi said regular monitoring during the trials reduced the risk of serious liver problems.

(Reporting by Ludwig Burger; Editing by Jason Neely and Conor Humphries)