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SEC recommends to waive off Phase IV study on Tocilizumab Injection for GCA

Gireesh Babu, New Delhi
Friday, January 20, 2023, 08:00 Hrs  [IST]

The expert committee, that recommends the nation’s drug regulator on approval of new drugs and clinical trials among others, has recommended to waive off the condition for conduct of Phase IV study on Tocilizumab Injection, indicated for Giant Cell Arteritis (GCA) imported and marketed by Cipla Ltd, considering it is very rare disease and there is challenge in recruitment of patients.

The Subject Expert Committee (SEC) for Analgesic and Rheumatology, which met on January 12, 2023, under the biological division considered the proposal of Cipla for waiver of condition to conduct Phase IV study which was given as a condition of import and market permission of Tocilizumab Injection (162 mg/0.9 mL pre-filled Syringe), indicated for GCA.

The company justified its proposal stating that it is 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 waive off the condition for conduct of Phase IV study as mentioned in import and marketing permission of the drug considering that Giant Cell Arthritis is very rare disease and there is challenge in recruitment of patients,” said the SEC after the meeting.

Further, the committee recommended that the firm should conduct an active surveillance study and should submit data on first 10 patients once completed. It should also submit protocol to the Central Drugs Standard Control Organisation (CDSCO) for evaluation, it added.

Cipla, according to reports, has tied up with Swiss pharma major Roche in the year 2018 to distribute the latter’s drugs including tocilizumab (Actemra) and Syndyma in India.

According to Roche, Actemra, approved for the treatment of rheumatoid arthritis (RA), paediatric juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), giant cell arteritis (GCA) and CAR-T cell-induced cytokine release syndrome (CRS) is a first in class anti-IL-6 receptor therapy, which is believed to play a key role in activating the inflammatory pathway that contributes to the signs and symptoms of RA and other inflammatory autoimmune conditions. It was also approved for defined patients hospitalised with severe or critical Covid-19 in multiple territories including the European Union, Japan, United Kingdom and others, it said.

According to the US-based Arthritis Foundation, GCA is an inflammatory disease affecting the large blood vessels of the scalp, neck and arms. The inflammation is caused by narrowing or blockage of blood vessels and women are more likely than men to develop GCA.

A study published in Neurology India in 2015 by a group of scientists including from Postgraduate Institute of Medical Education and Research, among others, said that a total of 72 patients were identified in India with the disease and the Indian patients with GCA have an earlier age of onset, and more ophthalmic complications.


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