CDSCO Panel allows Cipla to waive requirements for phase 4 study of tocilizumab inj for giant cell arthritis

Written by Dr. Divya Colin Published On 2023-01-19T18:00:26+05:30 | Updated On 19 Jan 2023 8:49 PM IST

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).

In addition, the expert panel opined the drug major Cipla to conduct an active surveillance study of the drug Tocilizumab and advised to submit data on the first 10 patients once completed.

This came after the firm presented its proposal for waiver of condition for the conduct of Phase IV study which was given as a condition of import and market permission of Tocilizumab Injection (162mg/0.9mL Prefilled Syringes) indicated for Giant Cell Arthritis (GCA) with the justification that they are facing challenges in recruitment of patients of GCA as it is an extremely rare disease with very low prevalence in India.

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.

Tocilizumab is an immunosuppressive drug, belonging to class interleukin-6 (IL-6) receptor inhibitors. It acts by inhibiting the activity of interleukin-6, the main inflammatory substance in our body. It is a recombinant humanized monoclonal antibody used to treat inflammatory and autoimmune conditions. It is used to treat Cytokine Release Syndrome (CRS), Systemic Juvenile Idiopathic Arthritis (sJIA), Giant Cell Arthritis (GCA), and Rheumatoid Arthritis (RA). Tocilizumab is also used to treat coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Tocilizumab has a long duration of action as it is generally given every 4 weeks and also has a wide therapeutic index. Patients have to be counselled regarding the risk of infections, GI perforation, and hepatotoxicity the drug might cause. Interleukin 6 (IL-6) is a pro-inflammatory cytokine produced by cells including T-cells, B-cells, lymphocytes, monocytes and fibroblasts. It binds to soluble and membrane-bound IL-6 receptors, preventing IL-6-mediated inflammation.

At the recent SEC meeting for Analgesic & Rheumatology held on 12th February 2023, the expert panel reviewed the proposal for waiver of condition for conduct of Phase IV study which was given as a condition of import and market permission of Tocilizumab Injection (162mg/0.9mL Prefilled Syringes) indicated for Giant Cell Arthritis (GCA) with the justification that they are facing challenges in recruitment of patients of GCA as it is an extremely rare disease with very low prevalence in India.

After detailed deliberation, the committee recommended to the waiver of the condition for the conduct of Phase IV study as mentioned in the import and marketing permission of the drug considering that Giant Cell Arthritis is a very rare disease and there is a challenge in the recruitment of patients.

Further, the committee recommended that the firm should conduct an active surveillance study and should submit data on the first 10 patients once completed.

"Accordingly, the firm should submit protocol to CDSCO for evaluation." the expert panel added.

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.