The Swiss drugmaker Roche has presented promising data for its experimental multiple sclerosis drug, fenebrutinib, positioning itself to seek regulatory approval for a treatment aimed at reducing relapse rates and slowing the progression of disability associated with the disease.
While the results from three late-stage trials indicate the drug’s efficacy, analysts are raising alarms about potential liver safety signals. This concern echoes a previous incident where the FDA rejected a competing MS therapy from Sanofi due to similar safety issues. Additionally, recent data revealed two drug-related fatalities among fenebrutinib patients, further complicating the risk-benefit analysis that regulators will face.
The outcome of Roche’s regulatory submission will not only impact the company’s portfolio but could also set a precedent for how safety signals are interpreted in the approval process for MS treatments.
Start your 7-day trial and see what the database can do →
