The Lancet Neurology published the results of the phase 3b NOVA study assessing the effectiveness of natalizumab administered every six weeks in the treatment of patients with relapsing-remitting multiple sclerosis.
The safety and comfort of the treatment of MS patients is improved
Published May 13, 2022 12:34
The results of the NOVA study show that natalizumab given intravenously every six weeks provides a high level of effectiveness in controlling MS activity in patients who switched from the every four weeks dosing regimen. The 6-week schedule has already been approved by the EMA.
- The NOVA study is the first prospective study to evaluate the natalizumab dosing regimen every six weeks in patients with relapsing-remitting MS. It is a source of important information about the continuing effect of dosing every four or six weeks. These results add to the knowledge based on the TOUCH Prescribing Program retrospective safety analyzes, which found that extending the dosing interval of intravenous natalizumab to an average of every 6 to 6 weeks correlates with a significantly lower risk of progressive multifocal leukoencephalopathy (PML) compared to with dosing approved every four weeks. This is another step towards a better understanding of the effects of the natalizumab six-week dosing regimen, explains Dr. John Foley, of Rocky Mountain MS Clinic, lead author of The Lancet Neurology.
Natalizumab is an established drug for the treatment of relapsing multiple sclerosis (MS) in adults and has been shown in clinical trials to slow the progression of disability, reduce the formation of new brain lesions and reduce the number of relapses. In the US, natalizumab is indicated as monotherapy for the treatment of patients with relapsing-remitting MS. In the European Union, it is indicated as monotherapy as a disease-modifying drug (DMT) in highly active adult patients with high-activity relapsing-remitting multiple sclerosis (RRMS) in the following patient groups: patients with highly active disease despite a complete and adequate treatment course of at least with a single course-modifying medicinal product or patients with rapidly evolving, severe RRMS. Natalizumab is authorized in over 80 countries, and over 260,000 people around the world have been treated with this drug, resulting in over a million patient years of experience from clinical trials and prescribing data.
press info
