AB Science has received a patent in Japan covering the use of its investigational oral therapy masitinib for progressive forms of multiple sclerosis (MS). The new patent — JP 7788154 — grants the France-based pharmaceutical company protection in the Asian nation through February 2041 on the use of masitinib…
Drug updates
People with multiple sclerosis (MS) who start treatment with a mild-to-moderate efficacy disease-modifying therapy (DMT) were more likely to switch to another DMT, an analysis of the German MS Registry finds. Starting a DMT between 2014 and 2017 was also a predictor of switching. Disease activity despite treatment…
Long-term use of Zeposia (ozanimod) did not adversely affect the heart of relapsing multiple sclerosis (MS) patients treated for one or two years in Phase 3 clinical trials, with no clinically significant changes in cardiac function reported. Data on people enrolled in the two studies were retrospectively evaluated, as the therapy…
The approved dosage of the multiple sclerosis (MS) therapy Ponvory (ponesimod) — 20 mg taken by mouth once daily — is appropriate for all adults with relapsing forms of MS, a new analysis of data from the OPTIMUM Phase 3 trial found. That analysis showed there was no…
Long-term treatment with Zeposia (ozanimod) stabilizes or even improves cognitive function in adults with relapsing forms of multiple sclerosis (MS), particularly among those with greater brain volumes. That’s according to five years of data from the completed SUNBEAM Phase 3 clinical trial (NCT02294058) and the ongoing…
Tysabri (natalizumab) given every six weeks was found to be similarly effective as the standard four-week dosing schedule at stopping nervous system damage in people with relapsing-remitting multiple sclerosis (RRMS). That’s according to the full results of the Phase 3b NOVA clinical trial, which compared Tysabri dosing schedules…
In a $3.68 billion transaction, Sanofi is preparing to acquire Principia Biopharma, a biopharmaceutical company focused on the development of therapies for disorders caused by dysregulation of the immune system, including multiple sclerosis (MS). The decision was unanimously approved by the board of directors 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…
Zeposia (ozanimod), a newly approved oral capsule treatment for relapsing forms of multiple sclerosis (MS), is now commercially available in the United States, its manufacturer, Bristol Myers Squibb, announced. “We are pleased to now bring Zeposia, an important new once daily treatment option, to [relapsing]…
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…
Relapsing-remitting multiple sclerosis (RRMS) patients on Gilenya (fingolimod) have fewer relapses and stay on treatment longer than those taking Tecfidera (dimethyl fumarate) or Aubagio (teriflunomide), according to a new study. The research, “Comparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis,” was published…
The U.S. Food and Drug Administration (FDA) has issued a safety alert, warning about a rare but life-threatening risk of stroke and artery rupture in patients with relapsing forms of multiple sclerosis (MS) being treated with Lemtrada (alemtuzumab). Since Lemtrada’s approval in 2014 to treat relapsing MS, 13…
Shortening the washout period to four weeks when switching from Biogen’s Tysabri to Novartis’ Gilenya is safe and reduces the chances of experiencing a disease flare in patients with relapsing-remitting multiple sclerosis (RRMS), a small Swiss study found. A four-week washout reduced the risk of having a disease relapse or an increase in disease activity, compared with an eight-week washout period, for two years after switching from Tysabri to Gilenya. Although Tysabri effectively slows worsening of MS symptoms and the appearance of disease flares, its use is under a strict risk management plan as it heightens the risk of developing a rare and life-threatening brain infection called progressive multifocal leukoencephalopathy, also known as PML. Some patients may switch to Gilenya, an alternative disease-modifying therapy for RRMS. Gilenya has been associated with a lower risk of PML infection and seen to reduce relapses, disability worsening, and the appearance of new brain lesions on clinical trials. It also is the only therapy approved by the U.S. Food and Drug Administration for children with MS as young as 10. When switching from Tysabri to Gilenya, it is important to consider the washout period, which is the period when the patient is taken off medications. If too long, it may lead to disease reactivation, which can be even stronger than before starting Tysabri. There is little evidence about the optimal length of washout periods, but a Phase 3 trial showed that an eight-week washout between Tysabri and Gilenya was beneficial compared with longer washouts of 12 or 16 weeks. The eight-week washout enabled more RRMS patients to become free from relapses and lowered disease activity. To study if a shorter washout period of four weeks further reduced the risk of MS reactivation, researchers conducted an open-label, observational study at the University Hospital, Basel, Switzerland. The study enrolled 25 RRMS patients who were appointed to switch from Tysabri to Gilenya. Participants were assigned to either a four-week or an eight-week washout period, and were followed for two years after switching to Gilenya. Although patients were older in the four-week washout group, disease activity and disability scoreswere not significantly different between groups at the beginning of the study. Relapses, disability scores, and disease activity on magnetic resonance imaging scans were recorded at baseline and weeks 8, 12, 16, 20 32, 56, and 108. In the first year (week 56) the proportion of patients with disease flare-ups or disease activity on MRI was not significantly different between the two washout groups, affecting 55.6% and 62.5% of the patients who had a four-week and an eight-week washout, respectively. However, at the end of the two-year follow-up (week 108), recurrent event analysis showed that patients who were on the four-week washout group were 77% less likely to experience relapses. The combined risk for relapse or disease activity on MRI also was 58% lower in the four-week group, compared with those who had an eight-week washout. In addition, researchers found that patients who had flares more frequently in the year before discontinuing Tysabri also had a nearly four times higher risk of experiencing relapses in the first year after switching to Gilenya. This suggests that the number of relapses before switching from Tysabri can predict disease reactivation once on other disease-modifying therapies. Both washout periods were deemed safe, with no serious adverse side effects or cases of opportunistic infections, including PML, being reported. Researchers emphasized, however, that the findings need to be confirmed in larger studies.
Mylan and Mapi Pharma will jointly develop and commercialize Glatiramer Acetate (GA) Depot, an investigative, long-lasting formulation of the commonly used multiple sclerosis (MS) therapy Copaxone (marketed by Teva Phatmaceutical). Under the terms of the partnership, Mylan will acquire global marketing rights for the therapy. The companies are in…
Biogen and AbbVie Voluntarily Withdraw Marketing Authorizations for MS Therapy Zinbryta You may have heard about this already, so forgive me if it’s not new to you, but it’s important information. A dozen cases of encephalitis or meningoencephalitis have been reported in patients using Zinbryta, and…
New data on the recently approved multiple sclerosis (MS) drug Ocrevus (ocrelizumab) will be presented at the upcoming American Academy of Neurology (AAN) Annual Meeting 2017, which will take place April 22-28 in Boston. The meeting is the first scientific conference focusing on neurology since the U.S.
Oral therapy Tecfidera (dimethyl fumarate) seems to be emerging as a first-line treatment for relapsing multiple sclerosis – according to Biogen, the company that developed it. That’s good news, and something we need to know. The company agrees that for some time, the long-term effectiveness and safety of this oral…
The world’s largest generic medicines manufacturer, Teva Pharmaceutical, is at the 31st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress currently ongoing in Barcelona, from October 7-10, 2015. Teva will be presenting the latest findings on its relapsing multiple sclerosis (MS) therapy COPAXONE® (glatiramer acetate injection), and product candidate for…
Israel-based biopharmaceutical company Teva Pharmaceutical Industries Ltd. announced last week that its thrice-weekly COPAXONE® (glatiramer acetate) 40mg/ml treatment for relapsing-remitting multiple sclerosis (RRMS) has received positive results in a decentralized procedure. The favorable outcome proceeds a Positive Assessment Report from the United Kingdom, the Reference Member…
The Food and Drug Administration (FDA) recently accepted the results from Genzyme’s TOWER and TOPIC clinical trials, which assessed the safety and efficacy of oral, once-daily Aubagio® (teriflunomide) for Multiple Sclerosis, and will add the positive data to the product’s U.S. label. Genzyme is a leader in the development…
This past Wednesday, September 10th, the largest, most anticipated multiple sclerosis (MS) convention — the 6th Joint ACTRIMS-ECTRIMS Triennial Meeting, MSBoston 2014 — kicked off with a whopping 8,000 registered attendees, all eager to learn more about the latest developments in MS. One of the highlights of the event…
As researchers continue to develop a clearer understanding of the underlying causes of multiple sclerosis (MS), it is becoming increasingly apparent that the future of treating the disease is likely to center on neural protection and a reversal of the demyelination process that strips away the critical insulation…