Drug updates

Ocrevus Reduces MS Relapse Risk, But Linked to More Hospitalizations As you can see from the first two paragraphs of this story, these hospitalizations occurred most frequently in older people with MS. Yet, as these researchers point out, the criteria for selecting the people who participated in Ocrevus’ clinical…

Trial Will Test Ocrevus on Arm, Hand Function in PPMS A lot of the focus in MS treatment and clinical trials is placed on walking ability. It seems to me that only recently has attention been paid to above-the-waist disabilities. I know that many people with MS have problems…

Tysabri (natalizumab) given every six weeks was as safe and effective over nearly 1.5 years of use as its approved four-week dosing in people with relapsing-remitting multiple sclerosis (RRMS), according to top-line data from the Phase 3b NOVA study. Tysabri is typically administered every four weeks, or about…

The U.S. Food and Drug Administration (FDA) has rejected an application requesting the expansion of Aubagio (teriflunomide) for the treatment of children and adolescents, ages 10 to 17, with relapsing forms of multiple sclerosis (MS). “The FDA deemed the data submitted were not sufficient to obtain approval of…

Gilenya (fingolimod) at its approved 0.5 mg daily dose continues to be the optimal dose for people with relapsing-remitting MS (RRMS), a systematic review of 11 clinical trials confirmed. A 0.25 mg/day dose, however, also showed improvement over placebo in MRI outcomes and patient satisfaction, the researchers noted, and further…

Mayzent (siponimod) and Zeposia (ozanimod), the two sphingosine-1-phosphate (S1P) receptor modulators most recently approved in Canada for treating multiple sclerosis (MS), showed strong launches in the country, according to the latest Spherix Global Insights’ report. However, due to several internal and external factors, sustained relevance of these…

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…

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…

Tecfidera (dimethyl fumarate), Gilenya (fingolimod), and Ocrevus (ocrelizumab) are losing ground to more recent therapies among U.S. multiple sclerosis (MS) patients switching treatment, according to the latest Spherix Global Insights’ report. The launch of MS generics, bioequivalents, and new brands in the U.S. market over the past year has increased…

SPMS Patient First to Be Treated With Antibody Given via Nasal Spray How great is this? As someone who gave himself an injection in his thigh for many years and received IV infusions for many more, an MS antibody treatment sprayed into the nose is wonderful news. This approval…

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…

FDA Approves Plegridy as Intramuscular Injection for Relapsing MS A common patient complaint about Plegridy has been that its subcutaneous injection procedure results in injection site reactions. This new formulation is delivered into the muscle, rather than under the skin. The needle is longer, but Biogen pharmaceuticals thinks the…

One of the key considerations when choosing a disease-modifying therapy (DMT) is how much it will disrupt your life. It’s one of several factors that need to be evaluated. Unlike shots and pills, infusion treatments can require a significant amount of time. That’s why the U.S. Federal Drug Administration’s December…

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…

Eli Lilly has reached an agreement to acquire Disarm Therapeutics, a biotechnology company developing a new class of disease-modifying treatments for patients with axonal degeneration, including those with multiple sclerosis (MS). In its announcement, Lilly committed to advancing Disarm’s prospective therapies, currently in preclinical development.

MS Patients Should Avoid ‘Silver’ Tooth Fillings Due to Mercury, FDA Advises Concerns about the possible danger of amalgam dental fillings have been floated for years. Several European countries already have banned their use in certain cases. Now, regulators in the U.S. have taken a small step in that…

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…

EMD Serono will present new data from programs assessing the efficacy and safety of Mavenclad (cladribine) and Rebif (interferon beta-1a), as well as investigative evobrutinib in treating relapsing forms of multiple sclerosis (MS) at the MSVirtual2020 meeting. Findings are part of 54 abstracts being presented by EMD Serono,…

Switching to Genentech’s Ocrevus (ocrelizumab) following suboptimal treatment responses significantly lessens symptoms and leads to high rates of no evidence of disease activity in people with relapsing-remitting multiple sclerosis (RRMS), according to data from a Phase 3b clinical trial. That finding, as well as data about patients’ adherence and…

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…

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…

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…

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…

FDA Extends Review of Ofatumumab for Relapsing MS to September The U.S. Food and Drug Administration (FDA) was expected to make a decision about ofatumumab, a self-administered injection of a monoclonal antibody, by this month. Now, it looks as if we’ll be waiting until fall. Ofatumumab is already approved…

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…

The U.S. Food and Drug Administration (FDA) approved adding new safety data on pregnancy and breastfeeding to the U.S. label for Rebif (interferon beta-1a), a disease-modifying treatment for relapsing forms of multiple sclerosis (MS). The label update draws on findings from a large population-based study, together with…

The European Medicines Agency (EMA) approved a shorter infusion time for Ocrevus (ocrelizumab), an approved treatment for people with relapsing or primary progressive multiple sclerosis (MS). The approval follows a positive recommendation from EMA’s Committee for Medicinal Products for Human Use (CHMP),…

Biogen has released new data on several of its therapies for multiple sclerosis (MS), including Vumerity (diroximel fumarate), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab). The data — six presentations — originally were to be presented at the 2020 annual conference of the American…

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…