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Sanofi's tolebrutinib drug delays progressive MS by 31% in trial



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Adds details and background throughout

By Ludwig Burger

FRANKFURT, Sept 20 (Reuters) -Sanofi SASY.PA said on Friday that its multiple sclerosis drug candidate was shown to delay worsening of a progressive form of the disease by 31%, as the French drugmaker eyes a request for approval later this year.

The company said earlier this month in a brief summary that the late-stage trial with the drug candidate tolebrutinib was successful. That mitigated a setback announced at the same time that trials on a more common relapsing form of the disease had failed.

Sanofi is pursuing several opportunities in MS, a debilitating nerve disease, to offset revenue losses after the recent end of MS pill Aubagio's patent protection, part of a push to become a powerhouse in anti-inflammatory drugs.

CEO Paul Hudson has made progress regaining investor confidence in the pharma pipeline since he unexpectedly abandoned 2025 margin targets last October to boost drug development spending.

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

They are designed to selectively block the harmful autoimmune reaction behind MS for a more targeted approach than standard immunosuppressant drugs.

Investors however have been kept on edge over revenue prospects because of a possible link of BTK inhibitors to liver damage and uncertain efficacy.

Sanofi said frequent monitoring during trials had mitigated serious liver problems.



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

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