CDSCO Panel Approves Dr Reddy's Laboratories Protocol Amendment Proposal to study Abatacept
New Delhi: The Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organisation (CDSCO), has approved Dr Reddys Laboratories protocol amendment proposal of the clinical trial titled “A randomised, double-blind, multicenter study comparing the efficacy, safety and immunogenicity of proposed Abatacept biosimilar (DRL_AB) with Orencia administered by the intravenous route as an add-on to methotrexate in the treatment of patients with moderate to severe rheumatoid arthritis”,
This came after Dr. Reddy's Laboratories presented protocol amendment Version 3.0 dated 02 Sep 2024, protocol no. AB-01-004.
Abatacept is a disease-modifying antirheumatic drug (DMARD) used in the management of rheumatic conditions, such as rheumatoid or psoriatic arthritis, and for the prophylaxis of acute graft-versus-host disease.
Abatacept is a selective costimulation modulator - like CTLA-4, the drug has been shown to inhibit T-cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. Blockade of this interaction has been shown to inhibit the delivery of the second co-stimulatory signal required for optimal activation of T-cells. This results in the inhibition of autoimmune T-cell activation that has been implicated in the pathogenesis of rheumatoid arthritis.
Abatacept is used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), and polyarticular juvenile idiopathic arthritis (pJIA), which are autoimmune disorders and is also used to prevent acute graft versus host disease (aGVHD).
At the recent SEC meeting for Analgesic and Rheumatology held on 19th March 2025, the expert panel reviewed protocol amendment Version 3.0 dated 02 Sep 2024, protocol no. AB-01-004
After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.
