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

Published 09/20/2024, 05:54 AM
Updated 09/20/2024, 10:11 AM
© Reuters. FILE PHOTO: The logo of French drugmaker Sanofi is seen a the Sanofi Genzyme Polyclonals in Lyon, France, September 30, 2023. REUTERS/Gonzalo Fuentes/File Photo
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By Ludwig Burger

FRANKFURT (Reuters) -Sanofi 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 (NASDAQ:SNY) 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 (NYSE:HUD) 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 (SIX:NOVN) and Roche.

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

© Reuters. FILE PHOTO: The logo of French drugmaker Sanofi is seen a the Sanofi Genzyme Polyclonals in Lyon, France, September 30, 2023. REUTERS/Gonzalo Fuentes/File Photo

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.

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