Novartis

Genentech’s Ocrevus (ocrelizumab) continues to be the most prescribed treatment for people with progressive forms of multiple sclerosis (MS) among U.S. neurologists, according to the latest Spherix Global Insights’ report. However, Novartis’ Mayzent (siponimod) “is beginning to close the gap” with Ocrevus among those with active secondary progressive MS…

Mayzent Approved for Active SPMS Patients in England and Wales This is great news for people with MS in England and Wales. Mayzent (siponimod) is a needed weapon in the MS battle. It is approved for use in active cases of secondary progressive MS (SPMS), while most other disease-modifying…

Mayzent (siponimod) has become the first oral medication to be approved for people with active secondary progressive multiple sclerosis (SPMS) in England and Wales. Following this decision by England’s National Institute for Health and Care Excellence (NICE) — which reversed its opinion announced in June — the…

The Scottish Medicines Consortium (SMC) has approved Mayzent (siponimod) for the treatment of active secondary progressive multiple sclerosis (SPMS) in Scotland. Mayzent, developed by Novartis, is a tablet taken once daily to counter a person’s disability progression. SPMS gradually develops from relapsing-remitting MS, and is…

Rituximab, an investigational B-cell depletion therapy that target CD20 to treat people with multiple sclerosis (MS), has significant effects on the characteristics of B-cells that return after treatment is stopped, with cells being less mature yet more activated toward a pro-inflammatory state, a study showed. Treatment also…

Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are similarly effective at lowering the frequency of relapses and delaying disability progression in people with relapsing-remitting multiple sclerosis (RRMS), a real-world study from Switzerland reported. These efficacy measures were also consistent whether patients were new to a disease-modifying therapy (DMT)…

The development of a diagnostic test using neurofilament light chain (NfL) — a biomarker for nerve cell damage — for people with multiple sclerosis (MS) will be part of a collaboration program between Siemens Healthineers and Novartis. The goal of this new collaboration is to design, develop,…

Among oral sphingosine-1-phosphate (S1P) receptor modulators for multiple sclerosis (MS), Novartis’s Gilenya (fingolimod) remains physicians’ favorite in the U.S., but prescriptions of recently-launched Bristol Myers Squibb’s Zeposia (ozanimod) are beginning to rise, according to a survey conducted by Spherix Global Insights. Also, COVID-19 not…

Novartis is not planning to open a clinical trial of Kesimpta (ofatumumab) as a potential treatment for primary progressive multiple sclerosis (PPMS) anytime soon, a company executive said. But it is well aware of the “unmet need” for therapy options among this patient group, and is exploring avenues. “We do…

Novartis will present the latest clinical data on three of its approved multiple sclerosis (MS) therapies — Kesimpta (ofatumumab), Mayzent (siponimod), and Gilenya (fingolimod) — at the  MSVirtual2020 meeting that opens today. The 8th joint meeting of the Americas Committee for Treatment and…

Upcoming and ongoing clinical trials aim to expand an understanding of Kesimpta (ofatumumab), the Novartis therapy recently approved by the U.S. Food and Drug Administration (FDA) to treat relapsing forms of multiple sclerosis (MS). Kesimpta is an anti-CD20 monoclonal antibody, a type of treatment that is thought to work…

Kesimpta (ofatumumab) is a safe and effective treatment for relapsing multiple sclerosis (MS), with an ease of delivery that makes it more convenient than comparable therapies, experts say. Developed and marketed by Novartis, Kesimpta was recently approved by the…

FDA Approves Kesimpta, B-cell Targeting Therapy for Relapsing MS The U.S. Food and Drug Administration’s approval of Kesimpta (ofatumumab) this month is a pretty big deal. Kesimpta is a once-a-month injectable disease-modifying therapy. There’s nothing else like it, because Kesimpta targets B-cells in the immune system. Until now, only…

The U.S. Food and Drug Administration (FDA) has approved Novartis‘ Kesimpta (ofatumumab) as a self-administered treatment for adults with relapsing forms of multiple sclerosis (MS), meaning those with clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). According to Novartis,…

Ofatumumab Seen as Superior to Aubagio at Lowering Relapse Rates in Phase 3 Trials Ofatumumab is a cancer medication that’s awaiting approval by the U.S. Food and Drug Administration and the European Medicines Agency to treat MS patients. It’s delivered by injection once a month and aims to reduce…

Rituximab is more effective and leads to fewer treatment discontinuations in people with multiple sclerosis (MS) than Gilenya (fingolimod) and Tecfidera (dimethyl fumarate), according to real-world data based on two years of therapy. Rituximab’s effectiveness appeared to be comparable to that of Tysabri (natalizumab), but with fewer…

About 20%, or 1 in 5, multiple sclerosis (MS) patients fail to adhere to oral disease-modifying therapies (DMTs) taken each day, and about 1 in 4 stop using a prescribed daily oral treatment within one year, a study based on reported real-world use found. The study “Real-world adherence to,…

Novartis‘ ofatumumab outperformed Aubagio (teriflunomide) at lowering the frequency of relapses and preventing disability progression among people with relapsing forms of multiple sclerosis (MS), a study based on clinical trial data reports. The study, “Ofatumumab versus Teriflunomide in Multiple Sclerosis,” was published in…

The National Institute for Health and Care Excellence (NICE) is recommending against Mayzent (siponimod) as a treatment for active secondary progressive multiple sclerosis (SPMS) in the U.K., because its cost-effectiveness relative to an existing treatment for these patients is not known. NICE’s draft guidance for Mayzent is open…

Gilenya May Help Control Severe Respiratory Disease in COVID-19 This story caught my eye, but not because of the possibility that Gilenya may help someone recover from COVID-19. It caught my eye because this information may give false hope to some people. Some doctors think that at a…

Gilenya (fingolimod), which works to modulate immune system activity in multiple sclerosis (MS), may benefit people with severe respiratory disease associated with COVID-19, a case report highlights. The study, “Severe COVID-19 infection in a patient with multiple sclerosis treated with fingolimod,” was published in…

By my unofficial count, disease-modifying therapy No. 19 has just become available to people with multiple sclerosis in the U.S. The U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) in late March. While pharmaceutical companies usually rush to make newly approved medications available to patients, with COVID-19 raging,…

The U.S. Food and Drug Administration (FDA) is extending its review of Novartis‘ ofatumumab, a possible self-administered injection therapy for relapsing multiple sclerosis (MS), the company announced. Originally expected in June, the FDA decision is now expected in September. “Novartis will continue to work with the FDA to…

Ofatumumab (OMB157) elicits a strong and fast reduction in the levels of circulating immune cells in people with relapsing forms of multiple sclerosis (MS), effectively helping to stop disease activity, according to new data from the Phase 2 APLIOS trial. The medication was also found to be more…

People with multiple sclerosis (MS) may not be at higher risk of developing a severe COVID-19 infection, according to preliminary data from patients in Italy. “At the moment, these results seem to be quite reassuring for most people with MS,” Marco Salvetti, MD, PhD, professor at Sapienza…

FDA Approves Bafiertam, Tecfidera Bioequivalent, for Relapsing MS This is the second disease-modifying therapy (DMT) OK’d by the FDA in the past few months. Bafiertam is a delayed-release pill that’s similar to Tecfidera, but it’s said that it has fewer side effects. Unfortunately, its manufacturer hasn’t yet made it…

People with relapsing multiple sclerosis (MS) being treated with Gilenya (fingolimod) for eight or more years show smaller increases in disability over 10 years than those using this treatment for a shorter time, a long-term follow-up study reports. Longer use of Gilenya also resulted in lesser disability progression,…

People with secondary progressive multiple sclerosis (SPMS) who began treatment with Mayzent early and continued its use for years are less likely to experience disability progression than those starting the medication later in their disease course, five-year data from the EXPAND study suggest. Data from this same Phase 3…

Prescriptions of Roche’s Ocrevus (ocrelizumab) among multiple sclerosis (MS) patients initiating or switching a disease-modifying therapy (DMT) continue to rise in Europe, according to a survey conducted by Spherix Global Insights. Ocrevus, an anti-CD20 monoclonal antibody administered directly into a vein, was approved in the European Union to treat active forms…

Treatment with Gilenya (fingolimod) could make people with multiple sclerosis (MS) more vulnerable to the parasitic infection known as cryptosporidiosis, a case report suggests. The report, “Cryptosporidiosis after treatment with fingolimod: a case report and pharmacovigilance review,” was published in the jorunal BMC Infectious Diseases. Gilenya…