Conduct India-specific Trial: CDSCO Panel Tells Roche on Satralizumab to Treat neuromyelitisoptica spectrum disorders
New Delhi: With an aim to establish the safety and efficacy of the Monoclonal Antibody Satralizumab in Indian patients, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the drug maker Roche to conduct an India-specific trial for the proposed drug.
This came after the firm presented its proposal for waiver of condition i.e. “Firm should carry out the global clinical study with India as one of the sites as proposed by the firm in the 64th SEC (Neurology & Psychiatry) meeting held on 15.12.2020” as stipulated in the import and market permission of Satralizumab (Y-DNA origin) solution for injection 120mg/mL PFS indicated as monotherapy or in combination with immunosuppressants for the treatment of adult and adolescent patients with neuromyelitisoptica spectrum disorders (NMOSD) with a justification that the firm has discontinued the global clinical trial study stating that it was feasible to recruit sufficient eligible patients.
Neuromyelitis optica spectrum disorder (NMOSD) is an uncommon yet impactful inflammatory and demyelinating disorder of the central nervous system. NMOSD primarily targets the optic nerves, brainstem, and spinal cord, presenting a unique set of challenges for diagnosis and management. NMOSD is an inflammatory disease that primarily affects the optic nerve and spinal cord; the brainstem, specifically the area postrema, can also be involved.
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