Sanofi’s experimental multiple sclerosis drug tolebrutinib has encountered two major setbacks: a delayed regulatory decision in the U.S. and a failed late-stage clinical trial.
The French drugmaker said the FDA’s decision on tolebrutinib for treating an advanced form of multiple sclerosis will likely be delayed, with additional guidance expected by the end of the first quarter, according to a Dec. 15 news release from the company.
The drug also did not meet Sanofi’s goal of delaying disability progression in patients with primary progressive multiple sclerosis, a condition that represents about 10% of the overall patient population. The company will not pursue regulatory approval for this indication.
Tolebrutinib’s development previously has faced challenges, including concerns about liver injury. The FDA had already extended its review in September by three months.
