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Sanofi’s riliprubart riliprubart gains Orphan Drug Designation status from Japan’s MHLW for CIDP

Sanofi’s antibody riliprubart has received orphan drug designation (ODD) from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its potential to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neurological disorder. In Japan alone, around 4,000 individuals have a CIDP diagnosis.

Riliprubart is a humanised immunoglobulin G4 (IgG4) monoclonal antibody inhibiting activated C1s within the classical complement pathway. In Japan alone, around 4,000 individuals have a CIDP diagnosis.

Sanofi neurology development global head Erik Wallstroem stated: “The orphan drug designation of riliprubart for people living with CIDP in Japan underscores our commitment to applying our deep understanding of the immune system to address rare neurological disorders with significant unmet medical needs.

“While CIDP therapies exist, many individuals continue to experience debilitating symptoms, including pain, fatigue and weakness. Our ongoing development of riliprubart reflects our dedication to challenging the status quo in neurology with the goal of improving people’s lives.”

A Phase II trial data indicates that riliprubart may offer sustained safety and efficacy over a 76-week period for a wide range of CIDP patients.

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