CDSCO Panel Flags Trial Death, Seeks Causality Report from Reliance Life Sciences on EtanerRel
New Delhi: Noting that there was one death during the trial, the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organization (CDSCO), has asked Reliance Life Sciences to submit a detailed causality assessment report before further review of its biologic EtanerRel (Etanercept for injection, r-DNA origin).
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. Ltd.) conducted vide Protocol No.: RLS/PMS/2018/03; Version 3.0, Dated: 14 Oct 2019."
Etanercept is a protein therapy based on the binding fragment of the tumour necrosis factor alpha receptor used to treat severe rheumatoid arthritis and moderate to severe plaque psoriasis.
EtanerRel (Etanercept) is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF. TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55- kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs). The mechanism of action of EtanerRel is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive. EtanerRel may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
EtanerRel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA).
EtanerRel can be initiated in combination with methotrexate (MTX) or used alone. EtanerRel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients two years and older. EtanerRel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). EtanerRel can be used with or without methotrexate.
EtanerRel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). EtanerRel is indicated for the treatment of patients four years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
EtanerRel is available as a multi-dose vial of lyophilized etanercept containing 25 mg of Etanercept, to be reconstituted with 1ml of bacteriostatic water for injection (reconstituted etanercept concentrate contains approximately 25 mg/mL of etanercept). EtanerRel is administered by subcutaneous (SC) injection.
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).
The committee noted that there was one death during the trial. After detailed deliberation, the committee recommended that the firm present the detailed causality assessment report of the death before the committee.
Causality assessment helps determine whether a reported adverse event, such as death, is directly linked to a drug or due to other factors. It plays a vital role in safeguarding patient safety and guiding regulatory decisions.
