Novartis presents promising new data on treatment for relapsing MS

Data showed that continuous treatment with Kesimpta was associated with fewer relapses and reduced risk of disability worsening 

The long-term data comes from the company's Phase 3 Asclepios I/II trials and Alithios open-label extension. Kesimpta maintained a similar safety profile as seen in Phase 3 trials, with no new safety risks identified over the four-year treatment period.  

Kesimpta was approved by the US Food and Drug Administration (FDA) in August, 2020. 

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage in the brain, optic nerves and spinal cord. It affects approximately 2.3 million people worldwide. Relapsing MS is a form of the disease where patients have relapses (symptoms worsen) and periods of stability in between relapses.  

In addition to demonstrating efficacy with four years of continuous treatment with Kesimpta, participants who switched from teriflunomide, an oral medication, to Kesimpta in the extension phase saw significant reductions in relapses and MRI lesions. 

Novartis Global Medical Franchise Head, Lykke Hinsch Gylvin, said the data supports Kesimpta as an “efficacious and well-tolerated" option for people living with relapsing MS.  

She said: “The sustained reductions in disability progression and lesion activity observed in those receiving continuous Kesimpta versus those who switched later from teriflunomide highlight the value of earlier treatment initiation with Kesimpta”.  

Additionally, data from the ongoing KYRIOS open-label, prospective study shows that people taking Kesimpta for MS can mount an immune response to mRNA COVID-19 vaccines. All participants in the study who were vaccinated during continuous Kesimpta treatment developed an immune response as soon as one week after initial vaccination.   

The FDA has approved more than a dozen medications for the treatment of relapsing forms of MS, which include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.