CDSCO Panel grants Novartis Protocol Amendment proposal for Remibrutinib study in Relapsing Multiple Sclerosis

The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years.

A second study of identical design (CLOU064C12302) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.

Remibrutinib belongs to a group of medicines called Bruton's tyrosine kinase (BTK) inhibitors. Bruton's tyrosine kinase is an enzyme that is essential for the survival and activation of B-cells.

Remibrutinib blocks BTK and prevents the release of histamine that causes itchy hives (wheals) and/or deep tissue swelling (angioedema). The mechanism of action of remibrutinib promotes rapid covalent binding to BTK targets and fast clearance of unbound drug thus preventing extended periods of drug exposure.

At the recent SEC meeting for Neurology and Psychiatry held on 18th and 19th January 2024, the expert panel reviewed the proposal presented by the drug major Novartis for the protocol amendment version 03 dated 20 February 2023 protocol no. CLOU064C12301.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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