IQVIA gets CDSCO panel okay to reopen trial recruitment in the country for Evobrutinib
New Delhi: Approving IQVIA proposal to amend Phase III Clinical Trail protocol of Bruton's tyrosine kinase (BTK) inhibitor Evobrutinib, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has recommended for the reopening of the trial recruitment in the country with the proposed protocol amendment.
This recommendation came after the firm presented the proposal for protocol amendment 4.0 dated 03-Apr-2022 under the Evolution RMS1 Phase III study protocol no. MS200527_0080 to re-open the trial recruitment in the country.
Evobrutinib is an inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Upon administration, evobrutinib inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway. This prevents both B-cell activation and BTK-mediated activation of downstream survival pathways, which leads to the inhibition of the growth of malignant B-cells that overexpress BTK.
Bruton's tyrosine kinase (BTK) regulates the functions of B cells and myeloid cells that are implicated in the pathogenesis of multiple sclerosis. Evobrutinib is a selective oral BTK inhibitor that has been shown to inhibit B-cell activation both in vitro and in vivo.
At the recent SEC meeting for Neurology and Psychiatry, the expert panel extensively evaluated the proposal presented by IQVIA for the protocol amendment of the Evobrutinib.
After detailed deliberation, the committee recommended for the re-opening of the trial recruitment in the country with the proposed protocol amendment.
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