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Novartis Submits sBLA and MAA to FDA and EMA for Monthly Subcutaneous CD20 Antibody Ofatumumab in Relapsing Multiple Sclerosis

Feb 24, 2020 07:40 CST Updated 07:40
Novartis

Drug Development and Manufacturing

FDA

U.S. Food and Drug Administration

European Medicines Agency

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.

On February 24, Novartis announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had respectively accepted its supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA) for ofatumumab (OMB157) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS). If approved, ofatumumab is poised to become the first B-cell therapy for RMS patients that can be conveniently self-administered via subcutaneous injection at home on a monthly basis.

 

Ofatumumab is a monoclonal antibody targeting CD20, which was approved by the FDA on October 26, 2009, for the treatment of chronic lymphocytic leukemia. The efficacy and safety of ofatumumab in treating relapsing multiple sclerosis (RMS) were demonstrated in two Phase III studies (ASCLEPIOS I and II). These studies showed that ofatumumab significantly reduced the number of relapses compared with teriflunomide. In these two studies, the annualized relapse rate (ARR) in the ofatumumab groups was 0.11 and 0.10, respectively, whereas in the teriflunomide groups, it was 0.22 and 0.25, corresponding to ARR reductions of 50.5% and 58.8%, respectively (p < 0.001 in both studies).

 

Furthermore, compared with teriflunomide, ofatumumab demonstrated a highly significant suppressive effect on gadolinium-enhancing (Gd+) T1 lesions, indicating that it can profoundly inhibit new inflammatory activity. In the pre-specified pooled analysis, ofatumumab reduced the relative risk of 3-month confirmed disability progression (CDP†) by 34.4% (p=0.002) and the relative risk of 6-month CDP by 32.5% (p=0.012).

 

Multiple Sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is one of the most common causes of neurological disability in adults, with onset typically occurring in young and middle adulthood, and it is more prevalent in women than in men. There are three main types of MS in adults: Relapsing-Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Primary Progressive Multiple Sclerosis (PPMS). RRMS is the most common type, accounting for approximately 85% of all MS cases.