Sanofi's MS Drug Tolebrutinib Falls Short in Relapsing Trials
Sanofi's leading multiple sclerosis (MS) drug candidate, tolebrutinib, has failed to meet the primary goals in two late-stage trials aimed at treating relapsing forms of the disease. The drug did not show significant efficacy in reducing relapse rates compared to the company's existing MS medication, Aubagio. This outcome has raised concerns about the prospects of tolebrutinib and its class of drugs, particularly due to potential links to liver damage and uncertain overall efficacy.
Despite these setbacks, a separate third late-stage trial indicated that tolebrutinib was effective in treating a progressive form of MS, a less common variant that currently lacks treatment options. Sanofi plans to discuss these mixed results with regulators and aims to file for approval by the end of 2024. The company is actively seeking new opportunities in the MS treatment landscape to offset revenue losses following the recent expiration of Aubagio's patent protection. CEO Paul Hudson has been working to regain investor confidence by boosting drug development spending and addressing challenges within the pharma pipeline.