CDSCO Panel Grants Novartis Protocol Amendment For Ofatumumab
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novartis protocol amendment request for Ofatumumab study.
This came after the firm presented protocol amendment version 03 dated 13 April 2023, Protocol no. COMB157G2399.
The study is an Open-label, single-arm, Multi-center Extension Study Evaluating the Long-term Safety, Tolerability, and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis.
The purpose of this study is to collect long-term safety, tolerability, effectiveness, and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical Multiple Sclerosis (MS) study.
Ofatumumab, a recombinant human anti-CD20 monoclonal immunoglobulin G1 antibody, was initially approved for the treatment of chronic lymphocytic leukemia and is now approved as a subcutaneous (SC) injection in several countries (including the USA , those in the EU and Japan) for the treatment of relapsing forms of MS.
At the recent SEC meeting for Neurology held on the 12th and 13th of December 2023, the expert panel reviewed the protocol amendment version 03 dated 13 April 2023, Protocol no. COMB157G2399, presented by the drug major Novartis.
After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.
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