Experts see tolebrutinib as part of a broader shift toward treatments that target the neurodegeneration in MS, not just its ...

Sanofi reports positive phase 3 HERCULES study data for tolebrutinib in non-relapsing secondary progressive multiple sclerosis, showing a 31% delay in disability progression. Study also revealed ...

(RTTNews) - French drug major Sanofi (SNY) announced Friday that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with ...

Tolebrutinib, from the $3.7 billion takeover of Principia in 2020, belongs to a class of compounds known as Bruton's tyrosine kinase (BTK) inhibitors, which has also attracted Novartis and Roche.

Sanofi said an oral treatment for multiple sclerosis, tolebrutinib, met its key goal in a Phase 3 study, potentially clearing the way for regulatory approval, although in two other studies ...

Positive results from the HERCULES phase 3 study showed that tolebrutinib, Sanofi’s oral brain-penetrant BTK inhibitor, met the primary endpoint of improvement over placebo in delaying time to ...

In a mitigation of the setback, Sanofi said a separate third late-stage trial showed that tolebrutinib met the main goal to treat a progressive - or steadily worsening - form of MS, which is less ...

Sanofi (SNY) is still testing tolebrutinib in the PERSEUS phase 3 study for primary progressive MS, evaluating time to onset of confirmed disability progression. Study results are expected in 2025.

Also Read: Sanofi’s Tolebrutinib Delays Disability Progression In Patients With Multiple Sclerosis, Data Shows. Sarclisa is the first anti-CD38 therapy in combination with standard-of-care VRd ...

In 2022, the FDA placed a partial clinical hold on Sanofi’s phase III studies on tolebrutinib in MS and myasthenia gravis (MG) indications after the regulatory agency identified cases of drug ...