EMD Serono

EMD Serono (Merck KGaA in Germany) is opening two pivotal and global Phase 3 clinical trials to evaluate the effectiveness and safety of oral evobrutinib in people with relapsing multiple sclerosis (MS). Evobrutinib, also known as M2951, works by blocking a protein called Bruton’s tyrosine kinase (BTK), which is…

Real-world data continues to support the safety and effectiveness of Mavenclad (cladribine tablets) in treating multiple sclerosis (MS), and several studies underway will help scientists gain in-depth understanding of how Mavenclad works, its impact on the immune system, and the durability of its benefits, an executive with EMD Serono said in an…

Using newer disease-modifying therapies (DMTs) as an initial treatment for children and adolescents with multiple sclerosis (MS) or clinically isolated syndrome (CIS) is associated with fewer relapses and brain lesions compared to the use of older and injectable DMTs, according to a real-world study in the U.S.

Medications for treating certain rare and chronic conditions,  including multiple sclerosis (MS), are now available from the specialty and home delivery pharmacy AllianceRx Walgreens Prime, the company announced. The newly included specialty medications are all limited distribution drugs (LDDs), which means the drug manufacturers have signed agreements giving very…

The Consortium of Multiple Sclerosis Centers (CMSC), working with the Foundation of the CMSC (FCMSC) and EMD Serono, launched a new Mental Health Mini-Mentorship Program to help clinicians better understand the psychological and mental health challenges that people with multiple sclerosis (MS) face on a daily…

FDA Approves Botox to Treat Upper Limb Spasticity in Children Aged 2 to 17 Botox injections have been approved to treat spasticity and bladder problems in adults with multiple sclerosis (MS) for years. It’s encouraging to see pediatric-onset MS receiving more attention and approval for medications. As MS is…

Results from a large observational study of pregnant women with multiple sclerosis (MS) treated with an interferon (IFN) beta-1a, like Rebif, before and during the first trimester showed no elevated risk of a miscarriage or ectopic pregnancy compared to those not using the medicine. This finding was presented at…

While neurologists favor Novartis‘ Mayzent (siponimod) for people with active secondary progressive multiple sclerosis (SPMS) and transitioning relapsing-remitting MS (RRMS), EMD Serono‘s Mavenclad (cladribine) could serve as a first option for patients with RRMS who failed initial therapy, Spherix Global Insights says in its…

Mavenclad (cladribine) tablets continue to show sustained efficacy and consistent safety in patients with relapsing forms of multiple sclerosis (MS), post-hoc analyses of a Phase 3 trial extension study show. The findings are set to be presented in several posters during the 5th Congress of the European…

Perched atop a lift at the intersection of Main and Third streets in downtown Los Angeles, artist Lydia Emily cheerfully answered questions from a reporter 2,500 miles away via cellphone while working on a mural three stories high. Periodically, she interrupted the interview to banter with co-workers, and gawking passersby.

Mavenclad (cladribine) may surpass Gilenya (fingolimod) in the category of oral disease-modifying therapy (DMT) of choice for the treatment of multiple sclerosis (MS) in Canada, according to a press release. The Canadian healthcare market for MS has grown considerably over the past two years. In November…

EMD Serono is supporting World MS Day, an initiative created by the Multiple Sclerosis International Federation (MSIF) to promote solidarity and raise awareness about multiple sclerosis (MS) worldwide, by joining efforts to make the disease more “visible.” Known as Merck KGaA…

EMD Serono, the biopharmaceutical division of Merck KGaA in the U.S. and Canada, announced the launch of the company’s Multiple Sclerosis Leadership and Innovation Network (MS-LINK), an interdisciplinary research community aimed at improving the care of individuals with multiple sclerosis (MS). The program will combine clinical outcomes…

Investigational therapy evobrutinib, also known as M2951, can reduce relapse rates and brain lesions in people with relapsing forms of multiple sclerosis (MS), 48-week data from a Phase 2 clinical trial suggest. Updated results from the trial (NCT02975349) were presented at the recent 2019 annual…

Mavenclad (cladribine) tablets stand out as a treatment for relapsing forms of multiple sclerosis (MS), providing two years of proven efficacy with a maximum of 20 days of oral treatment, a top executive with EMD Serono says. After being approved in more than 50 countries worldwide, including the European Union, Australia,…

I spend a great deal of time in my head. I think. A lot. Perhaps I do so more than I should, but then again, it is a haven at times. My thoughts run the gamut from the serious to the inane. Today my thoughts…

The U.S. Food and Drug Administration (FDA) has approved Mavenclad (cladribine) tablets for the treatment of adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS) and active secondary progressive disease (SPMS). Up to 85 percent of people with MS are initially diagnosed…

Evobrutinib, Merck KGaA’s oral candidate for relapsing multiple sclerosis (MS), is safe and can significantly reduce active brain lesions over 24 weeks of treatment, results of ongoing Phase 2 study show. Xavier Montalban, PhD, MD, with Vall d’Hebron University Hospital in Barcelona, presented the results in the talk “Primary…

EMD Serono has launched MS On My Mind with a goal of making people more aware of the emotional toll that multiple sclerosis (MS) can have on patients and caregivers. Patients are invited under the initiative to go to the MSIsOnMyMind.com website and finish the sentence “MS is on my…

Can Do Multiple Sclerosis and Embracing Carers are collaborating to help caregivers better understand the effects of multiple sclerosis (MS), and to help them take better care of themselves. The collaboration enlisted Can Do MS, which delivers health and wellness education programs to families living with MS, to…

Advances in multiple sclerosis research and the development of new treatments over the last several decades give sustained reasons for hope as continue moving toward our future, according to Jerry S. Wolinsky, a neurologist and MS specialist whose career spans more than 40 years. In a wide-ranging interview with Multiple…

Substantial data supporting both the effectiveness and safety of Mavenclad (cladribine tablets) is before the U.S. Food and Drug Administration (FDA), and may lead to its approval as a short-course oral treatment for people with relapsing-remitting multiple sclerosis (RRMS) some seven years after a first such request…

People with multiple sclerosis (MS) rarely get the opportunity to talk to the people who design their medications. But a new collaboration is providing that opportunity to a few of us. The Accelerated Cure Project for Multiple Sclerosis (ACP) and pharmaceutical manufacturer EMD Serono have begun working together…

The Accelerated Cure Project (ACP) for Multiple Sclerosis and EMD Serono— a unit of Merck KGaA —  will jointly incorporate the perspectives of U.S. and Canadian multiple sclerosis (MS) patients into the design and implementation of clinical trials. The ACP, a nonprofit group based in Waltham, Massachusetts, strives to accelerate…

Multiple sclerosis patients using Rebif (interferon beta-1a) are not at an increased risk of a stroke, even if remaining on this therapy for more than two years,  a study analyzing safety data from more than a dozen clinical trials and post-marketing surveillance shows. The…

Eighteen months after its entrance into the U.S. market, Genentech’s Ocrevus (ocrelizumab) has become the monoclonal antibody of choice to treat patients with multiple sclerosis (MS), according to a survey of nearly 100 neurologists across the U.S. Self-reported use of Ocrevus for the third quarter of 2018 surpassed…

Adults in Ireland with highly active relapsing multiple sclerosis (MS) now can be treated with Mavenclad (cladribine tablets, 10 mg), the first short-course oral treatment approved for this disease. The Irish Health Service Executive (HSE) has approved this new therapy and decided to reimburse patients for its associated…

Seven years after it first denied the request, the U.S. Food and Drug Administration accepted for review EMD Serono’s resubmitted New Drug Application (NDA) for cladribine tablets (brand name Mavenclad) as a treatment for patients with relapsing forms of multiple sclerosis (MS). The regulatory agency agreed EMD…

Cladribine tablets added to interferon-beta treatment significantly reduced the probability of relapses over 96 weeks in people with active relapsing multiple sclerosis , a Phase 2 clinical trial found. But a troubling diminishment in key immune cells was also seen in treated patients. Relapsing-remitting MS is marked by periods of flares caused by inflammatory attacks, followed by periods of partial or complete recovery . A majority --about 65 percent -- go on to develop secondary progressive MS. Despite the growing number of treatment options — including disease-modifying therapies — for these MS patients, efforts continue into better ways to lower relapse frequency and slow disease progression. Researchers tested the safety and efficacy of cladribine tablets as an add-on therapy in patients continuing to experience active relapses while under interferon-beta treatment. Cladribine is an oral medication that works by selectively targeting and reducing the number of immune cells involved in the inflammatory attacks occurring in active MS. It was developed by EMD Serono (Merck KGaA outside the U.S. and Canada) and approved in the European Union using the brand name Mavenclad (it is not approved in the U.S. for MS). Interferon-beta works by balancing pro- and anti-inflammatory signals, reducing the number of immune cells and promoting the survival of nerve cells. Interferon-beta therapies are marketed under several brand names; in the study, researchers analyzed patients using Rebif (marketed by EMD Serono), Avonex (by Biogen), and Betaseron/Betaferon (by Bayer). The 96-week, randomized, double-blind, Phase 2b trial called ONWARD enrolled a total of 172 patients with active relapsing MS, who were randomly divided into two groups: those given cladribine tablets together with interferon-beta, and those that received a placebo and interferon-beta. Results showed those taking cladribine tablets together with interferon-beta had 63% lower likelihood of a relapse compared to those given an add-on placebo. Add-on cladribine treatment also reduced most measures of disease activity as assessed by magnetic resonance imaging (MRI) — namely, the number of new brain and spinal cord lesions. However, almost half of patients in this treatment group developed lymphopenia, a condition where the levels of lymphocytes (important immune white blood cells) in the blood are abnormally low. None in the control group developed the condition. Other reported side effects, including other serious adverse side effects, were identical in the two groups. Altogether, the findings indicate that a cladribine and interferon-beta combination can successfully lower the probability of relapses over the course of 96 weeks, but also increase a person's chances of lymphopenia.

Cladridine may be effective in preventing disability progression and reducing damage to nerve cells in people with progressive forms of multiple sclerosis (MS), researchers suggest based on a case study of two such patients given the injectable treatment. MS is characterized by progressive degeneration of cells in the central nervous system, mostly…