Submit complete safety data: CDSCO panel tells Novartis on Remibrutinib

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the drug maker Novartis to submit complete safety data of the ongoing study of Bruton's tyrosine kinase inhibitor Remibrutinib till date for further review by the committee to allow an extension of the current study.

Bruton's tyrosine kinase inhibitor Remibrutinib demonstrates promising efficacy and safety in chronic spontaneous urticaria.

This came after the firm presented the proposal for a grant of Phase III clinical trial permission with Protocol No. CLOU064A2303B; Version: 00 dated 30-May-2022.