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Sanofi’s HERCULES Data In MS May Offer Path To Approval For Tolebrutinib

 
• By Joseph Haas

Delaying disease progression in non-relapsing secondary multiple sclerosis may get the BTK inhibitor approved, despite previous pivotal trial failures in relapsing MS.

Man with Multiple Sclerosis standing in his accessible kitchen with a cane
Sanofi's drug may address progressing disability related to MS • Source: Alamy

Sanofi likely bolstered the chances of its multiple sclerosis candidate tolebrutinib finding a treatment niche on 20 September as it reported data from the Phase III HERCULES study showing that the BTK inhibitor can delay disability progression in non-relapsing secondary progressive MS (nrSPMS) while demonstrating what one analyst called a manageable liver safety profile.

Key Takeaways

  • Sanofi’s BTK inhibitor tolebrutinib may offer a delay in confirmed disability in a subset of MS patients, new data from a Phase III study shows.

The data, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference in Copenhagen, came roughly...

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