Ofatumumab is under clinical development by Novartis and currently in Phase III for Relapsing Multiple Sclerosis (RMS). According to GlobalData, Phase III drugs for Relapsing Multiple Sclerosis (RMS) have an 87% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Ofatumumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Ofatumumab overview

Ofatumumab (Arzerra) is an antibody. It is formulated as injection solution for intravenous route of administration. It is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) refractory to fludarabine and alemtuzumab. Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Arzerra is used to treat chronic lymphocytic leukaemia (CLL). Arzerra indicated for the treatment of chronic lymphocytic leukaemia relapsed or refractory cd20 positive, for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. Arzerra in combination with fludarabine and cyclophosphamide (FC) is indicated for the treatment of patients with relapsed chronic lymphocytic leukaemia (CLL).

Ofatumumab in combination with bendamustine is under development for the treatment of follicular lymphoma relapsing multiple sclerosis including relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS), and recurrent multiple sclerosis. The drug candidate is also under development for acute lymphoblastic leukemia as first-line therapy. It was under development for the treatment of refractory non-Hodgkin’s lymphoma, pemphigus vulgaris, rheumatoid arthritis (RA), indolent B-cell non-Hodgkin's lymphoma, extranodal marginal zone B-Cell lymphoma, chronic obstructive pulmonary disease (COPD) and diffuse large B-cell lymphoma (relapsed and refractory patients). It is administered orally and subcutaneously.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

For a complete picture of Ofatumumab’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.