Drug information

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…

Treatment with Mavenclad (clabridine) reduces the frequency of relapses in people with relapsing-remitting multiple sclerosis (RRMS), with benefits appearing to be evident two years after patients stopped taking the treatment, new data suggest. These findings were in the study, “Analysis of frequency and severity of relapses…

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…

The number of cases of Tysabri (natalizumab) that are associated with progressive multifocal leukoencephalopathy (PML) — a serious brain infection — in multiple sclerosis (MS) patients living in Sweden fell between 2006 and 2018, a study shows. Notably, the data highlighted that this drop was likely due to…

Tecfidera (dimethyl fumarate) was detected in the breast milk of two women using the oral therapy to treat their multiple sclerosis, but at concentrations well below the “theoretical threshold of concern” for an infant, a case study reported. According to its investigators, this is the first…

Eligible people with relapsing-remitting multiple sclerosis (RRMS) now have access to Mavenclad (cladribine) through seven provincial public drug plans in Canada, including the Régie de l’assurance maladie du Québec (RAMQ) and the Ontario Drug Benefit Exceptional Access Program. The oral treatment now is available through public drug programs…

Aslan Pharmaceuticals announced it will develop Aslan003, a potent and highly selective next-generation modulator of the immune system, as a potential therapy for autoimmune diseases such as multiple sclerosis (MS). Aslan003 is a small molecule blocking the human enzyme dihydroorotate dehydrogenase (DHODH). This enzyme is believed to reduce…

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…

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,…

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 —…

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…

Tecfidera (dimethyl fumarate) is safe and effective as a long-term treatment for relapsing-remitting multiple sclerosis (RRMS), a study of clinical trial data covering up to 11 years of treatment suggests. The study, “Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis:…

Generic formulations of dimethyl fumarate — currently sold as Tecfidera by Biogen — were given a green light to enter the U.S. market, after a federal court invalidated a patent protecting Tecfidera from generic competition as a multiple sclerosis (MS) treatment.  The ruling by the District Court for the…

After being rejected twice in the last four years, Fampyra (fampridine; marketed as Ampyra in the U.S.) is now being recommended by the Scottish Medicines Consortium (SMC) for use in the country’s National Health System (NHS) to treat walking disabilities in adults with multiple sclerosis (MS). Scotland…

Tysabri (natalizumab) is safe and shows robust, real-world effectiveness at reducing the frequency of relapses in people  with relapsing-remitting multiple sclerosis (RRMS), 10 years of data from a large, observational study report. Findings were reported in “Long-term safety and effectiveness of natalizumab treatment…

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…

Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by the forum post “MS Treatment Eases Flare-up Symptoms After 2 Months” from Oct.

ANI Pharmaceuticals is asking the U.S. Food and Drug Administration (FDA) for the right to reintroduce in the U.S. market its Cortrophin Gel (repository corticotropin injection, 80 U/ml) to treat acute exacerbations in multiple sclerosis (MS) and other diseases. Currently, the only repository corticotropin injection available in…

The risk of invasive cancer may be slightly higher in multiple sclerosis (MS) patients treated with Gilenya (fingolimod) compared with those treated with rituximab, and with people from the general population, a Swedish study suggests. The study, “Cancer Risk for Fingolimod, Natalizumab, and Rituximab…

Rituximab is barely detected in breast milk of women with relapsing-remitting multiple sclerosis (RRMS) who took the therapy while breastfeeding their child, small study shows. Results suggest that women with RRMS can continue with a disease-modifying treatment while breastfeeding. The study “Minimal breast milk transfer of…

Gabapentinoids — a class of therapies sometimes used off-label to help control pain in people with multiple sclerosis (MS) — can increase the risk of serious breathing problems, particularly for those who have risk factors like poorer lung function or use opioid pain medicines, according to a warning…

People with relapsing-remitting multiple sclerosis (RRMS) across Canada are a major step closer to having access to EMD Serono’s Mavenclad (cladribine). EMD Serono, known as Merck KGaA outside of North America, has finish negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) that oversees new drugs coming in,…

Prices for new multiple sclerosis (MS) therapies in the United States are decided most by competitors’ prices, and continual increases in the cost of existing treatments by concerns for company profits and future growth, a study based on”confidential” interviews with four biotech executives with experience in the MS field reports. U.S.

Pharmascience recently launched pms-Fingolimod, a generic version of Novartis’ Gilenya (fingolimod), to treat adults with relapsing-remitting multiple sclerosis (RRMS) in Canada. The new generic is now available in that country, and has demonstrated efficacy and safety similar to Gilenya. Generic medicines are chemically identical to the original branded therapy, but carry a…

Seven months after starting a safety review of Lemtrada (alemtuzumab), the Pharmacovigilance Risk…

Teva Canada announced that Teva-Fingolimod 0.5 mg capsules, a bioequivalent generic version of Novartis’ Gilenya (fingolimod), are now available in Canada and approved by the country’s national health system called Health Canada. Generic medicines are chemically identical to the original branded therapy, but carry a significantly lower cost. Canadian…

The U.S. Supreme Court gave a green light to generic versions of Ampyra this week, declining to hear Acorda Therapeutics‘ appeal of a lower court ruling that allowed generics of its treatment for walking or gait problems in multiple sclerosis. That lower court ruling came from the U.S. District Court…

Celgene‘s oral ozanimod, if approved, could be a first-line oral treatment option for people with relapsing multiple sclerosis (MS), and one with relatively minor side effects. Recent results from the Phase 3 trials RADIANCE (NCT02047734) and…

Treatment with Lemtrada (alemtuzumab) is associated with the death of patients with relapsing-remitting multiple sclerosis (RRMS) more often than previously reported and appears to be most common during the first month, according to a European review. The study, “Adverse events with fatal outcome associated…

A first healthy volunteer has enrolled in a randomized, double-blind Phase 1 study to compare the gastrointestinal (GI) tolerability and safety of oral Tecfidera to Bafiertam, an oral bioequivalent in treating relapsing forms of multiple sclerosis (MS), Banner Life Sciences…