Press Release: Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
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Sanofi has received priority review from the FDA for tolebrutinib, a potential breakthrough therapy for non-relapsing secondary progressive multiple sclerosis (nrSPMS). The drug is unique in its ability to cross the blood-brain barrier and target smoldering neuroinflammation, which could potentially slow disability progression. The target action date for FDA decision is September 28, 2025.
March 25, 2025 | 6:15 am
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POSITIVE IMPACT
Tolebrutinib's priority review represents a potential significant milestone for Sanofi's neurology pipeline, offering a novel approach to treating multiple sclerosis by targeting neuroinflammation.
Priority FDA review suggests strong clinical data and potential market opportunity for Sanofi's innovative MS treatment. Successful approval could significantly boost the company's neurology portfolio and revenue.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 100