CDSCO Panel allows Cipla to waive requirements for phase 4 study of tocilizumab inj for giant cell arthritis
New Delhi: Considering that Giant Cell Arthritis is very rare disease and there is challenge in recruitment of patients, the Subject Export Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Cipla's proposal for waiver of condition for conduct of Phase IV study of Tocilizumab Injection (162 mg/0.9m L Prefilled Syringes).
Giant cell arteritis (GCA), also called temporal arteritis, is an inflammatory autoimmune disease of large blood vessels. Symptoms may include headache, pain over the temples, flu-like symptoms, double vision, and difficulty opening the mouth. Complication can include blockage of the artery to the eye with resulting blindness, as well as aortic dissection, and aortic aneurysm. GCA is frequently associated with polymyalgia rheumatica.
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