Sanofi said on Friday that its multiple sclerosis drug candidate was shown to delay worsening of a progressive form of the disease by 31 per cent, as the French drug maker 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 US$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 and Roche.
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.