Conduct India-specific Trial: CDSCO Panel Tells Roche on Satralizumab to Treat neuromyelitisoptica spectrum disorders

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.

Satralizumab is a humanized monoclonal antibody medication that is used for the treatment of neuromyelitis optica spectrum disorder, a rare autoimmune disease. It is a subcutaneously injected anti-IL-6 receptor monoclonal antibody for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

Satralizumab is a subcutaneously administered, humanised monoclonal antibody that binds to membrane-bound and soluble IL-6 receptors, preventing IL-6 from binding and inhibiting the IL-6 signaling pathways involved in inflammation.

At the recent SEC meeting for Neurology and Psychiatry held on the 18th and 19th of January 2024, the expert panel reviewed the proposal presented by the drug major Roche.

After detailed deliberation, the committee recommended that the firm should conduct an India-specific trial to establish the safety and efficacy of the drug in Indian Patients.

Accordingly, the expert panel suggested that the firm should submit an India-specific clinical trial protocol to CDSCO for further evaluation by the committee.

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