Novartis

Novartis said it will petition the U.S. Supreme Court to uphold a patent that protects the dosing regimen of Gilenya (fingolimod) that’s approved for relapsing forms of multiple sclerosis (MS). The original patent was not set to expire until the end of 2027, which meant generic versions…

People with relapsing multiple sclerosis (MS) treated with Tysabri (natalizumab) or Gilenya (fingolimod) are less likely to have disease activity than those on low-efficacy MS medications, according to a small study conducted in Japan. Results also showed that patients receiving the high-efficacy therapies had less brain shrinkage,…

Kesimpta (ofatumumab) may be more effective at reducing relapse rates than other disease-modifying therapies (DMTs) in Japanese adults with relapsing forms of multiple sclerosis (MS), according to a review of clinical trial data. Although the differences were not statistically significant, the study provided comparative evidence that may help…

People with relapsing forms of multiple sclerosis (MS) who were continuously on Kesimpta (ofatumumab) for up to four years were about four times more likely to have no evidence of disease activity than those initially on Aubagio (teriflunomide), according to updated data from the ASCLEPIOS and ALITHIOS…

Gilenya (fingolimod) and Tysabri (natalizumab) were more effective at lowering relapse rates in children with multiple sclerosis (MS) than interferon-beta, according to a recent meta-analysis. Findings like these can be leveraged for better clinical trial design, the researchers wrote. If used to determine “historical” relapse rates that…

Kesimpta (ofatumumab) is now accessible to eligible Canadians with relapsing-remitting multiple sclerosis (RRMS) through public drug plans in Ontario and Quebec. The treatment has been included as an exceptional medication under both the Ontario Drug Benefit Exceptional Access Program and the Régie de l’assurance maladie du Québec. This…

Serum levels of neurofilament light chain (NfL) — proteins found in nerve cell projections — can help in the prediction of disease progression among people with relapsing forms of multiple sclerosis (MS), according to an analysis of data from two large Phase 3 trials. The researchers said that NfL…

Treatment with Gilenya (fingolimod) for up to four years was found safe and lowered relapse rates among people with multiple sclerosis (MS) in the Czech Republic, according to a real-world study called GOLEMS. Older age, lower disability level, and fewer relapses prior to the treatment’s start were all…

Treatment with Kesimpta (ofatumumab) for more than three years revealed no new or unexpected safety findings, and continued to slow disability progression and prevent the development of new brain lesions in people with relapsing multiple sclerosis (MS), according to new clinical trial data. Information from another trial also…

Multiple sclerosis (MS) treatments belonging to the class of sphingosine 1-phosphate (S1P) receptor modulators — such as Mayzent (siponimod) and Gilenya (fingolimod) — may be associated with a greater likelihood of skin cancer, results from a real-world study suggest. The association was the greatest for a form of…

Ocrevus (ocrelizumab) may be more effective than Gilenya (fingolimod) at preventing relapse in relapsing-remitting multiple sclerosis (RRMS) patients who recently transitioned from Tysabri (natalizumab), according to a new study. Ocrevus is “potentially a better exit strategy than [Gilenya] after [Tysabri] cessation, with an impressive reduction [in] risk…

A decision by the U.S. Court of Appeals for the Federal Circuit has upheld the validity of a patent for dosing Novartis’ oral multiple sclerosis (MS) treatment Gilenya (fingolimod), the medication’s manufacturer announced. “With this decision, Novartis confirms that it expects no generic versions of Gilenya in the…

The U.S. Food and Drug Administration (FDA) has agreed to review TG Therapeutics’ application seeking the approval of ublituximab as a treatment for people with relapsing forms of multiple sclerosis. An FDA’s decision is expected on or before Sept. 28. The agency is not currently planning to hold an…

People in Australia with multiple sclerosis (MS) and certain other medical conditions will have access to new and expanded medications — including Kesimpta — now listed on the Pharmaceutical Benefits Scheme (PBS). Having these medications on the PBS will lower treatment costs for MS patients and their…

People with relapsing-remitting multiple sclerosis (RRMS) have switched to treatment with Gilenya (fingolimod) at an earlier stage in their disease in recent years, compared to individuals who switched to the treatment around the time it became available, a new study indicates. The findings suggest “an increased experience in…

Adults in Scotland with active relapsing-remitting multiple sclerosis (RRMS) will now have access at low or no cost to Kesimpta (ofatumumab), the first self-administered, at-home B-cell-targeting therapy for people with the neurodegenerative disease. The Scottish Medicines Consortium (SMC) recommended that the Novartis therapy be available through the…

The multiple sclerosis (MS) treatment Gilenya (fingolimod) is associated with a 16% greater risk of infections, compared with a placebo or control treatment, according to data from 12 randomized clinical trials. The findings were published in a study, “Incidence and Risk of Infection Associated With Fingolimod in Patients…

Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17–22. Go here to read the latest stories from the conference. Note: This story was updated April 21, 2021, to clarify that Kesimpta will be available in the next three months…

Kesimpta (ofatumumab) has been approved in the U.K. as the first self-administered, at-home, B-cell-targeting therapy for people with relapsing forms of multiple sclerosis (MS) and active disease. More specifically, the approval includes patients with either clinically isolated syndrome, relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS), who have…

The European Commission has approved Novartis’ Kesimpta (ofatumumab) as the first self-administered, at-home B-cell-targeting therapy for adults with relapsing forms of multiple sclerosis (MS) and active disease. Active disease in these forms, which include clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS),…

Health Canada has approved Kesimpta (ofatumumab) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) who have active disease, as defined by clinical and imaging features. In contrast with other B-cell-targeting therapies used in MS, patients can self-administer a precise dose of Kesimpta at home using the Sensoready…

In recognition of National Multiple Sclerosis (MS) Awareness Month — celebrated throughout March — Novartis and iHeartRadio are teaming up on a virtual event to celebrate the resilient spirit of people affected by MS. Called “A Night for MS Awareness,” the event will be streamed on…

People with multiple sclerosis (MS) and their nurses prefer the Sensoready autoinjector pen for subcutaneous self-administration of Kesimpta (ofatumumab) over other methods for injecting treatments, according to a survey. The survey was conducted by Novartis, which markets Kesimpta. Full findings from the survey will be presented at…

A branch of the European Medicines Agency (EMA) has recommended that Kesimpta (ofatumumab) be approved and made available to treat relapsing forms of multiple sclerosis (MS) in adults with active disease. A final decision from the European Commission (EC) is expected in about two months. Typically, the EC follows…

Kesimpta (ofatumumab), the first self-administered B-cell therapy to treat relapsing forms of multiple sclerosis (MS), is now available via AllianceRx Walgreens Prime, one of the largest specialty and home delivery pharmacies operating in the U.S., to patients living in the country. The specialty pharmacy — which focuses on serving…

Mayzent (siponimod) significantly improved cognitive processing speed in people with secondary progressive multiple sclerosis (SPMS) compared with a placebo, according to additional analyses of two-year data from the EXPAND Phase 3 trial. While…

Novartis has partnered with iHeartRadio to launch the first free on-demand streaming radio station dedicated to the multiple sclerosis (MS) community. Named MS Vibes, the station is focused “on popular music, educational content and relatable topics to which listeners can connect, uplift and recharge,” Leverne Marsh, vice president and…

Treatment with Tysabri (natalizumab) was more effective than Gilenya (fingolimod) in helping people with relapsing–remitting multiple sclerosis (RRMS) achieve no evidence of disease activity, a head-to-head study suggested. The study, “BEST-MS: A prospective head-to-head comparative study of natalizumab and fingolimod in active relapsing MS,” was…

Phase 3 Trial of Sativex, Cannabis Extract Treatment for MS Spasticity, Opens in US This is a major step toward making a clinically tested, cannabis-based medication available in the U.S. I’ve always thought that medications containing a THC/CBD combination are useful to lessen some MS symptoms, but the lack…

Adults with active relapsing-remitting multiple sclerosis (RRMS) treated with Tysabri (natalizumab) had fewer new and accumulated lesions, and a lower relapse rate than those treated with Gilenya (fingolimod) for 24 weeks, according to…