IQVIA gets CDSCO panel okay to reopen trial recruitment in the country for Evobrutinib

Published On 2022-10-26 08:00 GMT | Update On 2022-10-26 08:00 GMT

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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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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IQVIA gets CDSCO panel okay to reopen trial recruitment in the country for Evobrutinib

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