relapsing MS

The U.S. Food and Drug Administration (FDA) has approved an intramuscular injection formulation of Plegridy (peginterferon beta-1a) to treat people with relapsing forms of multiple sclerosis (MS). This formulation, for injection directly into muscle, is what is typically used to deliver the flu shot. According to Biogen, Plegridy’s…

A stem cell transplant can prevent disability progression and maintain disease remission over long periods of time in most patients with relapsing forms of multiple sclerosis (MS) who failed to respond adequately to disease-modifying therapies (DMTs), a study reports. The study, “Long-Term Clinical Outcomes of Hematopoietic…

Changes in the amount of grey matter in specific regions of the brain appear to occur early in relapsing multiple sclerosis (MS), while structural changes in white matter happen late in disease progression. These were among the findings of a recent study that tracked the sequence of events in…

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…

Two global Phase 3 clinical trials, both comparing Sanofi Genzyme’s investigational tolebrutinib with its approved therapy Aubagio, are enrolling a total of 1,800 people with relapsing multiple sclerosis (MS), the company said. All patients in both studies — dubbed GEMINI 1 and GEMINI 2 — will…

Prior treatment with disease-modifying therapies (DMTs) does not affect the long-term benefits of Aubagio (teriflunomide) in treating relapsing forms of multiple sclerosis (MS), according to a review study. The study, “Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis,”…

Lupin‘s generic equivalent of Tecfidera has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple sclerosis (MS), the company announced in a press release. The therapy — dimethyl fumarate delayed-release capsules — is indicated for use in people with clinically…

The U.S. Food and Drug Administration (FDA) has approved Cipla’s dimethyl fumarate capsules, a generic version of Biogen’s Tecfidera, to treat adults with relapsing forms of multiple sclerosis (MS), the company announced in a press release. This generic is packaged as 120 mg or 240 mg…

Roche has launched a Phase 3 clinical trial program to evaluate fenebrutinib, its investigational oral BTK inhibitor, in people with relapsing forms of multiple sclerosis (MS) and primary progressive MS (PPMS). Data on fenebrutinib’s potency and selectivity, as well as the design of the clinical…

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…

Janssen Pharmaceuticals’ investigational oral therapy ponesimod is superior to Sanofi’s Aubagio (teriflunomide) in delaying disability progression in adults with relapsing multiple sclerosis (MS), according to exploratory analyses of OPTIMUM clinical trial data. These and other findings from Janssen’s MS research program, including on the health…

Bafiertam (monomethyl fumarate), a bioequivalent of Tecfidera to treat relapsing forms of multiple sclerosis (MS), is now available to patients in the U.S. through a network of specialty pharmacies, Banner Life Sciences, the therapy’s developer, announced. Banner previously stated that Bafiertam would arrive on the market…

Zeposia (ozanimod) oral capsules continue to safely and effectively prevent relapses and disability progression in people with relapsing forms of multiple sclerosis (MS), according to three-year data from a Phase 3 extension clinical trial. “Gaining insight into long-term therapeutic outcomes can enable clinicians to identify the most appropriate…

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…

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,…

Mylan announced the launch of a first generic version of Tecfidera, a treatment for relapsing forms of multiple sclerosis (MS). The generic, now approved by the U.S. Food and Drug Administration (FDA), is the first generic of any MS treatment available in an oral solid —…

Aubagio (teriflunomide), taken as a 14 mg tablet once a day, shows long-term safety and efficacy in patients with relapsing forms of multiple sclerosis (MS), according to results of the Phase 3 TOWER extension study. Treatment was generally well tolerated by the 751 patients using Aubagio for a median…

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…

Walking abilities decline earlier and faster than arm and hand function in people recently diagnosed with multiple sclerosis (MS), particularly those with progressive MS (MS), a study showed. These findings, which are consistent with those reported in a previous natural history study called NARCOMS, suggest an ascending order of…

Banner Life Sciences announced that Bafiertam (monomethyl fumarate) will become available to adults with relapsing forms of multiple sclerosis (MS) in the United States beginning in September. The U.S. Food and Drug Administration (FDA) approved Bafiertam in April as a bioequivalent to Biogen’s Tecfidera…

Mavenclad (cladribine) prevents relapses and disease progression in more than half of patients with relapsing forms of multiple sclerosis (MS) for at least five years after the last dose, according to a real-life study from Italy. These findings, based on real-world data from Italian MS patients previously treated…

A first person has enrolled in Sanofi’s Phase 3 trial evaluating SAR442168, an oral BTK inhibitor intended to treat relapsing forms of multiple sclerosis (MS), Sanofi’s partner, Principia Biopharma, announced. “We are delighted that Sanofi has initiated … [this] trial in patients with relapsing MS,” Roy Hardiman, chief…

Mapi Pharma, supported by an additional $20 million investment from its partner Mylan, will continue a Phase 3 trial assessing the safety, tolerability, and efficacy of GA Depot, its long-acting, once-a-month injectable formulation of glatiramer acetate. The study (NCT04121221), which opened in October 2019,…

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…

Note: This story was updated May 27, 2020, to note a change in the protocol of the EVOLUTION trials, which are now comparing evobrutinib with Aubagio, rather than Avonex, along with updated NCT numbers. The investigational oral medication evobrutinib leads to a sustained reduction in relapse rates…

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,…

Sanofi will host an online science session to present results of a Phase 2b clinical trial testing the safety and efficacy of its investigational, oral BTK inhibitor SAR442168 in people with multiple sclerosis (MS). The virtual session, owing to the cancellation of the American Academy…

Monthly under-the-skin injections of Novartis’ investigational candidate ofatumumab show promise as a convenient, effective, and safe therapeutic option for people with relapsing multiple sclerosis (MS). Data from the ASCLEPIOS and APLIOS clinical trials showed that ofatumumab — currently under regulatory review for possible approval in the U.S. and Europe…

The U.S. Food and Drug Administration (FDA) has approved Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease (SPMS). Vumerity (previously known as ALKS 8700) was developed by Alkermes…

A new Phase 3 clinical trial to explore the safety and efficacy of Mapi Pharma’s once-a-month injectable formulation of glatiramer acetate — named GA Depot — has started enrolling patients with relapsing multiple sclerosis (MS). The trial (NCT04121221) is expected to enroll approximately 960 participants, 18 to 55…