European regulators recommend Sanofi's MS drug tolebrutinib for approval after US rejection

European Medicines Agency officials issued a positive recommendation for tolebrutinib, an experimental multiple sclerosis therapy from Sanofi, after the U.S. FDA rejected the drug earlier this year over safety concerns.

The EMA recommendation focuses on patients with secondary progressive multiple sclerosis who have not experienced a relapse in the past two years, and a final marketing authorization decision is expected in the coming months.

If approved, the drug-planned to be sold as Cenrifki-would let Sanofi begin recouping its investment from the 2020 $3.7 billion acquisition of Principia Biopharma that added the BTK inhibitor to its portfolio.

Tolebrutinib belongs to a newer class of Bruton’s tyrosine kinase inhibitors, originally developed for cancer treatment but now being pursued for autoimmune conditions such as multiple sclerosis.