Drug information

Sometimes it seems as if people with MS are asked to flip a coin to make what’s arguably the most important decision about their treatment: which disease-modifying therapy (DMT) to use. More than 20 DMTs are approved in the U.S., similar to what’s available in the rest of the…

Two global Phase 3 clinical trials comparing fenebrutinib, an investigational oral BTK inhibitor by Roche, with Aubagio (teriflunomide) are now enrolling adults with relapsing forms of multiple sclerosis (MS), the National MS Society announced in a press release. The twin studies, called FENhance 1 (NCT04586023)…

Subtle Medical announced the granting of a U.S. patent for its radiology software that uses artificial intelligence to improve the quality of medical imaging, with the potential to reduce the amount of gadolinium, a contrast agent, needed to one-tenth of its usual dose. Gadolinium, a heavy metal, is included in…

Treatment with Zeposia (ozanimod) significantly reduces the risk of relapse, decreases the proportion of patients experiencing a relapse, and has a better safety profile than Aubagio (teriflunomide) for people with relapsing multiple sclerosis (MS), according to an indirect comparison of clinical trial data.

FDA Rejects Under-the-skin Tysabri for Relapsing MS I expect this decision will be a disappointment for those who had hoped to be able to self-administer highly effective Tysabri as a shot rather than an IV infusion. But I switched from Avonex to Tysabri, because after a few years of…

The U.S. Food and Drug Administration (FDA) has rejected Biogen‘s request for approval of under-the-skin administration of Tysabri (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS). “This response from the FDA does not affect the intravenous administration of Tysabri, a well-established high-efficacy treatment with a…

TG Therapeutics has expanded its contract with Samsung Biologics to manufacture ublituximab, an investigational therapy for relapsing forms of multiple sclerosis (MS). “Samsung is the global leader in biologics manufacturing and we are happy to have them as our partner as we look forward to the potential commercialization…

Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, held April 17–22. Go here to read stories from the conference. After starting treatment with the multiple sclerosis (MS) therapy Mavenclad (cladribine), some types of immune cells are more affected…

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. Vumerity (diroximel fumarate) continues to be safe and well-tolerated, in addition to reducing measures of disease activity in people…

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. Treating multiple sclerosis (MS) in its earlier stages with Ocrevus (ocrelizumab) can substantially lower disease activity and lessen damage…

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. A majority of the relapsing-remitting multiple sclerosis (RRMS) patients given Mavenclad (cladribine) tablets in the CLARITY Phase 3 trial did…

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. Disease-modifying therapies (DMTs) that target CD20 are associated with worse outcomes from COVID-19 in multiple sclerosis (MS) patients, an…

#AANAM – COVID-19 Often Leads to Flares in MS Patients, Survey Finds I’ve read more than a few social media posts from people with MS who are concerned that the COVID-19 vaccines will cause a flare. National MS Association guidelines say the vaccines may cause a temporary, mild fever…

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…

Interim data from a Phase 2 trial of Immunic Therapeutics’ investigational oral therapy IMU-838 (vidofludimus calcium) in relapsing-remitting multiple sclerosis (RRMS) patients has established a once-daily, 30 mg dose as the most appropriate for future Phase 3 trials. The…

A 78-year-old man with multiple sclerosis (MS) developed the brain infection progressive multifocal leukoencephalopathy (PML) after two years of treatment with Ocrevus (ocrelizumab), a recent case report detailed. Treatment was discontinued and, as the patient’s symptoms worsened, he was moved to off-label…

Vumerity (diroximel fumarate) is easier on the gastrointestinal tract than Tecfidera (dimethyl fumarate), and this translates into better quality of life for patients with relapsing-remitting multiple sclerosis (RRMS), a new analysis of EVOLVE-MS-2 trial data has found. The study, “Improved gastrointestinal profile with diroximel fumarate is…

Where has the time gone? It’s been three years since I completed my second round of Lemtrada (alemtuzumab) infusions. So, it’s time to take another look at where this journey has taken me. Lemtrada is a monoclonal antibody treatment that wipes out rogue B- and T-cells in the…

The overall cost of disease-modifying therapies for multiple sclerosis (MS) in the U.S. remained stable from 2018 to 2020, according to pharmacy and medical claims data from Prime Therapeutics’ insured members. This stabilization derived from a balance between a reduction in Copaxone (glatiramer acetate injection) use due…

The European Commission (EC) has approved a new method to administer Tysabri (natalizumab) as a treatment for people with relapsing-remitting multiple sclerosis (RRMS). This new delivery route involves a subcutaneous injection in which Tysabri is injected under the skin. Compared with the previously approved intravenous (into the bloodstream) formulation,…

Previous treatment with oral Gilenya (fingolimod) is associated with a suboptimal response to Lemtrada (alemtuzumab) and an increased risk of secondary autoimmune disorders in multiple sclerosis (MS) patients, a study reports. However, Lemtrada showed an efficacy in patients switching from various other disease…

Prolonging a cellular defense mechanism shown to restore myelin — the protective sheath around nerve cell fibers that is lost in multiple sclerosis (MS) — may be key to treating the neurodegenerative disease, a study in MS mouse models suggests. That defense mechanism, called integrated stress response (ISR), helps…

For a first time, an immune-modulating antibody will be given via nasal administration to treat a person with secondary progressive multiple sclerosis (SPMS). The U.S. Food and Drug Administration (FDA) approved a request to use the antibody — a fully human anti-CD3 monoclonal antibody called foralumab — under an…

Off-label treatment with Tysabri (natalizumab) significantly lessens disease activity and reduces the number of relapses per year in patients with pediatric-onset multiple sclerosis (POMS), real-world data from Portugal show. The treatment also was considered safe in this population, in agreement with earlier studies. These findings support the usefulness…

A branch of the European Medicines Agency has recommended that Ponvory (ponesimod) be approved to treat relapsing forms of multiple sclerosis (MS) in adults with active disease. This positive opinion from agency’s Committee for Medicinal Products for Human Use (CHMP) covers clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary…

The journal JAMA Neurology recently reported that a 78-year-old man with progressive multiple sclerosis died after being diagnosed with progressive multifocal leukoencephalopathy (PML), a brain disease. The man, diagnosed with MS about 30 years ago, had been treated for two years with Ocrevus (ocrelizumab), and had no previous…

Injecting rituximab — a cancer therapy sometimes used in multiple sclerosis — into the spinal canal of people with progressive forms of MS did not demonstrably lower inflammation or improve clinical conditions, according to the results of a small trial. “Contrary to the initial high expectations, no clear-cut effect on…

Ponvory (ponesimod) Approved for Adults With Relapsing Forms of MS Add one more medication to the disease-modifying therapy (DMT) arsenal. Ponvory is a once-a-day pill that aims to reduce immune system activity. It’s similar to Aubagio (teriflunomide), which I used for about two years, and which I believe helped…

Ocrevus (ocrelizumab) treatment may delay the need for a wheelchair by seven years in patients with primary progressive multiple sclerosis (PPMS), a study reports. This delay, drawn from clinical trial data on treatment- versus placebo-group patients and supported by real-world findings, likely translates to long-term benefits for PPMS patients,…

Mavenclad (cladribine) reduces the number and volume of lesions in patients at risk of multiple sclerosis (MS) after a first clinical demyelinating event, a study based on Phase 3 trial data found. A demyelinating event occurs when myelin — the protective coating around nerve fibers — experiences damage; this…