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.
Remibrutinib is an oral treatment that potently and selectively inhibits Bruton's tyrosine kinase (BTK) enzyme, which plays a critical role in the inflammatory activity of certain immune cells such as B-cells and microglia.
Remibrutinib inhibits an enzyme called “Bruton's tyrosine kinase,” reducing the activation of B cells, which are immune cells that play a role in the response that affects the brain and spinal cord in MS.
Remibrutinib reduced the need for rescue medication and improved symptoms among patients with chronic spontaneous urticaria.
At the recent SEC meeting for dermatology and allergy held on 13th April 2023, the expert panel reviewed the proposal for the grant of permission to conduct the Phase III clinical trial of the LOU064 (Remibrutinib).
After detailed deliberation, the committee recommended that the firm should submit complete safety data of ongoing study till date for further review by the committee to allow an extension of the current study.
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