Tolebrutinib's SPMS Path Stalls Amid Severe Liver-Safety Concerns

A recent account says tolebrutinib’s US path for non-relapsing secondary progressive MS appears to have stopped after FDA concerns about severe liver injury and uncertain benefit in the intended population. It reports six Hy’s Law cases among roughly 2,700 treated people, including a transplant and death; this is a serious safety and regulatory development, not a new treatment option.