New safety and tolerability data further strengthens Kesimpta's role in RMS

Swiss pharma giant Novartis (NOVN: VX) today announced that new data from the ALITHIOS open-label extension study was published in the peer-reviewed Multiple Sclerosis Journal.

The data showed that with up to 3.5 years of treatment with Kesimpta (ofatumumab), no incidences of opportunistic infections were reported, and observed COVID-19 infections showed no evidence of an increase in incidence or severe outcomes in adults with relapsing forms of multiple sclerosis (RMS). Mean immunoglobulin G (IgG) levels remained stable and immunoglobulin M (IgM) levels remained above the lower limit of normal in most patients. The overall incidence of serious infections was low and no new safety risks were identified. This study, which included 1,969 RMS patients, provides a robust picture of the continuous safety data for Kesimpta.

“The cumulative safety data suggest that treatment with Kesimpta over an extended period of time is well tolerated in adults with RMS and support the long-term use of Kesimpta in all RMS patients, including early MS patients,” said Lykke Hinsch Gylvin, neuroscience global medical franchise head at Novartis Pharmaceuticals.