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CDSCO Panel Flags Trial Death, Seeks Causality Report from Reliance Life Sciences on EtanerRel
['Susmita Roy', 'Mpharm', 'Pharmacology']
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This came after Reliance Life Sciences presented the Clinical Study Report (CSR) of the Phase IV study titled “A prospective, multi-centre, phase IV study to evaluate safety and efficacy profile of EtanerRel TM (etanercept manufactured by Reliance Life Sciences Pvt.
EtanerRel (Etanercept) is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF.
EtanerRel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).
At the recent SEC meeting for Analgesics and Rheumatology, the expert panel reviewed the Clinical Study Report (CSR) of the Phase IV study of Reliance Life Sciences' EtanerRel (Etanercept for injection, r-DNA origin).
After detailed deliberation, the committee recommended that the firm present the detailed causality assessment report of the death before the committee.
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