Sanofi’s Tolebrutinib Drug Delays Progressive MS by 31% in Trial, According to Reuters

By Ludwig Burger

FRANKFURT – Sanofi announced on Friday that its drug candidate for multiple sclerosis has been demonstrated to delay the worsening of a progressive form of the disease by 31%. The French pharmaceutical company is considering submitting a request for approval later this year.

Earlier this month, Sanofi provided a brief update indicating that the late-stage trial for the drug candidate tolebrutinib was successful, which alleviated concerns following the announcement of failed trials for a more common relapsing form of the disease.

Sanofi is exploring various avenues in the treatment of multiple sclerosis, a debilitating nerve disorder, as it seeks to compensate for revenue losses following the expiration of its MS medication Aubagio’s patent. This effort is part of the company’s strategy to establish itself as a leader in the field of anti-inflammatory drugs.

CEO Paul Hudson has been working to regain investor confidence in the pharmaceutical pipeline after he unexpectedly withdrew margin targets for 2025 last October to increase spending on drug development.

Tolebrutinib, acquired through the $3.7 billion purchase of Principia in 2020, belongs to the class of compounds known as Bruton’s tyrosine kinase (BTK) inhibitors, which have also garnered interest from other major pharmaceutical companies.

These inhibitors aim to selectively block the harmful autoimmune reactions associated with multiple sclerosis, providing a more targeted treatment approach compared to conventional immunosuppressant drugs.

Despite these advancements, investors have remained apprehensive about revenue forecasts due to potential concerns regarding BTK inhibitors’ links to liver damage and uncertain efficacy. Sanofi has stated that frequent monitoring during trials has helped to mitigate serious liver complications.