Sanofi reports tolebrutinib submission accepted for FDA priority review

The U.S. Food and Drug Administration is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis and to slow disability accumulation independent of relapse activity in adult patients, Sanofi (SNY) announce. The target action date for the FDA decision is September 28. A regulatory submission is also under review in the EU, the company noted. The PERSEUS phase 3 study of tolebrutinib in patients with primary progressive MS is currently ongoing with study results anticipated in the second half of 2025. Erik Wallstrom, Global Head of Neurology Development, said: “The totality of data across our clinical program validates our scientific understanding of smoldering neuroinflammation as a distinct inflammatory process in MS. People living with non-relapsing secondary progressive multiple sclerosis or who experience disability independent of relapse activity suffer from disability that worsens over time due to persistent inflammation in the brain, known as smoldering neuroinflammation, which is the primary driver of disability. The demonstrated ability of tolebrutinib to delay disability by targeting underlying drivers of the disease represents a potential paradigm shift in treating these patients.”