CDSCO Panel Approves Novartis Protocol Amendment Proposal For Multiple Sclerosis Drug Ofatumumab

This came after Novartis presented protocol amendment version 01 dated 17July 2023 protocol no. CBAF312D2301.

The above study is to determine the efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.

The study is divided into a Core Part and an Extension Part. The Core Part is a 24-month, double-blind, triple dummy, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is a 60-month (5-year) open-label (except for the first 12 weeks of transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria. The targeted enrollment is 180 participants with multiple sclerosis which will include at least 5 participants with body weight (BW) ≤40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms. There is a minimum 6-month follow-up period for all participants (core and extension). The total duration of the study could be up to 7 years.

Ofatumumab is the first fully human anti-CD20 monoclonal antibody (mAb) developed and tested for subcutaneous (SC) self-administration at monthly doses of 20 mg, and has been approved in the US, UK, EU, and other regions and countries worldwide for the treatment of relapsing multiple sclerosis.

Multiple sclerosis (MS) is a chronic autoimmune and degenerative disorder affecting the central nervous system (CNS), and B and T cell interactions are thought to play a critical role in its pathogenesis.

The development of B-cell-depleting anti-CD20 monoclonal antibody (mAb) therapies has led to a better understanding of the role of B and T cells in this disease, and, most importantly, has led to a new appreciation of the central role of B cells in MS pathophysiology.

Ofatumumab works by binding to and blocking the action of CD-20, a molecule expressed on the surface of both healthy and leukemic B lymphocytes. In patients with previously untreated chronic lymphocytic leukemia (CLL), ofatumumab caused B-cell depletion in the peripheral blood after six months following the last dose.

At the recent SEC meeting for Neurology and Psychiatry held on 18th and 19th January 2023, the expert panel reviewed the protocol amendment version 01 dated 17 July 2023 protocol no. CBAF312D2301 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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