Add geographically distributed Govt sites: CDSCO Panel tells Dr Reddy's on antirheumatic drug Abatacept study
New Delhi: The drug major Dr Redyy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of the antirheumatics drug Abatacept, a disease-modifying antirheumatic drug (DMARD) used in the management of rheumatic conditions.
However, this approval is subject to the condition that the firm should include a more geographically distributed government site.
This came after Dr Redyy's Laboratories presented Phase I clinical trial study protocol No. AB-01-001.
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 the 16th of January 2023, the expert panel reviewed the Phase I clinical trial study protocol No. AB-01-001.
After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial as presented by the firm with the condition that the firm should include more geographically distributed government sites.
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