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).
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