Submit Justification to study Tocilizumab in patients with giant cell arteritis: CDSCO Panel Tells Cipla
New Delhi: Reviewing the protocol presented by the drug major Cipla for the approval post-marketing active surveillance of Tocilizumab in patients of giant cell arteritis, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should submit scientific justification/rationale for the study.
This came after the drug major Cipla presented the protocol for the conduct of post-marketing active surveillance of Tocilizumab titled “A post-marketing active surveillance of Tocilizumab in patients of giant cell arteritis” vide study code CP/01/23 version 01 dated 12.06.2023.
Giant cell arteritis is an inflammation of the lining of arteries. Most often, it affects the arteries in the head, especially those in temples. For this reason, giant cell arteritis is sometimes called temporal arteritis.
Giant cell arteritis frequently causes headaches, scalp tenderness, jaw pain, and vision problems. Untreated, it can lead to blindness.
Tocilizumab injection is in a class of medications called interleukin-6 (IL-6) receptor inhibitors. Tocilizumab is an interleukin-6 (IL-6) receptor antagonist used to treat Cytokine Release Syndrome (CRS), Systemic Juvenile Idiopathic Arthritis (sJIA), Giant Cell Arteritis (GCA), and Rheumatoid Arthritis (RA).
Tocilizumab is used to treat rheumatoid arthritis and juvenile idiopathic arthritis. It may also be used to treat giant cell arteritis, and cytokine release syndrome, and to slow a decrease in lung function for patients with systemic sclerosis-related lung disease.
At the recent SEC meeting for analgesic and rheumatology held on the 8th and 9th of November 2023, the expert panel reviewed the protocol presented by the drug major Cipla for the conducting the post-marketing active surveillance of Tocilizumab titled “A post-marketing active surveillance of Tocilizumab in patients of giant cell arteritis” vide study code CP/01/23 version 01 dated 12.06.2023.
After detailed deliberation, the committee opined that the firm should submit scientific justification/rationale for the study and sample size.
Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO for further evaluation by the committee.
