September 20, 2019 News by Ana Pena PhD #ECTRIMS2019 – Ahead for Mavenclad: Fuller Understanding of What Makes It ‘Unique,’ Serono Exec Says in Interview Real-world data continues to support the safety and effectiveness ofĀ MavencladĀ (cladribineĀ 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 SeronoĀ said in an…
September 16, 2019 News by Jose Marques Lopes, PhD #ECTRIMS2019 – Newer DMTs More Effective Than Older Injectables in Pediatric MS, Study Says 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.
August 16, 2019 News by Marisa Wexler, MS MS Therapies Among Limited Offerings Through AllianceRx Walgreens Prime Medications for treating certain rare and chronic conditions, Ā 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…
July 15, 2019 News by Joana Carvalho, PhD CMSC Opens Weeklong Mental Health Program to Help Mentor and Train MS Specialists 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…
July 8, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Botox for Kids, Kids’ Healthcare Needs, Mavenclad, MS Fatigue Diet 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…
July 8, 2019 News by Alberto Molano, PhD Miscarriage or Ectopic Pregnancy Not More Likely in Women Using Rebif, Study Suggests Results from a large observational study of pregnant women with multiple sclerosis (MS) treated with an interferon (IFN) beta-1a, likeĀ 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…
July 2, 2019 News by Ana Pena PhD Neurologists Prefer Mayzent for SPMS and RRMS, But Mavenclad Could Be ‘Ideal’ First Switch, Report Suggests 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…
June 28, 2019 News by Joana Carvalho, PhD Mavenclad Continues to Demonstrate Sustained Efficacy, Safety in Patients with Relapsing Forms of MS, Post-hoc Analyses Show 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…
June 12, 2019 News by BioNews Staff Muralist Lydia Emily Uses Art to Publicize Hardships of Life with MS Perched atop a lift at the intersection of Main and ThirdĀ 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.
June 3, 2019 News by Joana Carvalho, PhD Mavenclad May Surpass Gilenya as DMT of Choice for Treatment of MS in Canada 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…
June 3, 2019 News by Joana Carvalho, PhD EMD Serono and ‘MS Inside Out’ Campaign Join Global Effort to Make MS More ‘Visible’ EMD SeronoĀ is supportingĀ 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…
May 21, 2019 News by Santiago Gisler EMD Serono Launches MS-LINK Research Network to Improve Patient Care 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…
May 20, 2019 News by Marisa Wexler, MS #AANAM ā Evobrutinib Continues to Show Potential for MS, 48-week Phase 2 Data Suggest Investigational therapy evobrutinib, also known as M2951, can reduce relapse rates and brain lesions in people with relapsing forms of multiple sclerosis (MS), 48-weekĀ data from a Phase 2 clinical trial suggest. Updated results from the trial (NCT02975349) were presented at the recent 2019 annual…
April 22, 2019 News by Jose Marques Lopes, PhD Two-year Efficacy with Short-course Treatment Sets Mavenclad Apart, EMD Serono Executive Says Mavenclad (cladribine) tablets stand out as a treatment for relapsing forms ofĀ multiple sclerosisĀ (MS), providing two years of proven efficacy with a maximum of 20 days of oral treatment,Ā a top executive with EMD SeronoĀ says. After being approved in more than 50 countries worldwide, including theĀ European Union,Ā Australia,…
April 18, 2019 Columns by Jennifer (Jenn) Powell The DMT Decision: Tried and True or Shiny and New? 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…
April 1, 2019 News by Joana Carvalho, PhD FDA Approves EMD Serono’s Mavenclad as Treatment for RRMS and Active SPMS 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) andĀ active secondary progressive disease (SPMS). Up to 85 percent of people with MS are initially diagnosed…
March 4, 2019 News by Patricia Inacio, PhD #ACTRIMS2019 – Evobrutinib Significantly Reduces Brain Lesions in Relapsing MS, Phase 2 Trial Shows Evobrutinib, Merck KGaAās oral candidate for relapsing multiple sclerosis (MS), is safe and can significantly reduce active brain lesions overĀ 24 weeks of treatment, results of ongoing Phase 2 study show. Xavier Montalban, PhD, MD, withĀ Vall d’Hebron University HospitalĀ in Barcelona, presented the results in the talk āPrimary…
November 5, 2018 News by Iqra Mumal, MSc ‘MS On My Mind’ Aims to Help Others Better Understand Disease Through Words and Art EMD Serono has launched MS On My MindĀ 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 theĀ MSIsOnMyMind.comĀ website and finish the sentence “MS is on my…
October 31, 2018 News by Mary Chapman Collaboration Formed to Further MS Education, and to Help MS Caregivers 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…
October 16, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Evobrutinib and Other Reasons for Hope in Pursuit of MS Treatments, Jerry Wolinsky Says in Interview Advances in multiple sclerosisĀ research and the development of new treatments over the last several decades give sustained reasons for hope as continue moving toward our future, according toĀ Jerry S. Wolinsky, a neurologist and MS specialist whose career spans more than 40 years. In a wide-ranging interview with Multiple…
October 15, 2018 News by BioNews Staff #ECTRIMS2018 – Post-hoc Analyses Support Safety and Efficacy of Mavenclad, Merck KGaA Says 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…
October 12, 2018 Columns by Ed Tobias MS Patients Capture the Ear of a Pharma Company 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 SclerosisĀ (ACP) and pharmaceutical manufacturer EMD Serono have begun working together…
October 9, 2018 News by Janet Stewart, MSc EMD Serono, ACP Work Jointly to Make MS Clinical Trials More Patient-focused The Accelerated Cure Project (ACP) for Multiple SclerosisĀ andĀ EMD Seronoā a unit of Merck KGaA ā Ā will jointly incorporate the perspectives of U.S. and CanadianĀ multiple sclerosis (MS) patients into the design and implementation of clinical trials. The ACP, a nonprofit group based in Waltham, Massachusetts, strives to accelerate…
October 1, 2018 News by Ana Pena PhD MS Patients Using Rebif Not at Higher Stroke Risk, Even Over Long-term, Study Reports Multiple sclerosis patients usingĀ RebifĀ (interferon beta-1a) are not at an increased risk of a stroke, even if remaining on this therapy for more than two years,Ā a study analyzing safety data from more than a dozen clinical trials and post-marketing surveillance shows. The…
September 21, 2018 News by Alice MelĆ£o, MSc Ocrevus Climbing as First-line DMT for RRMS Among Neurologists Surveyed in Spherix Report Eighteen months after its entrance into the U.S. market,Ā Genentechās 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 theĀ third quarter of 2018 surpassed…
September 5, 2018 News by Alice MelĆ£o, MSc Mavenclad Approved to Treat Highly Active Relapsing MS Patients in Ireland 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…
July 31, 2018 News by Alice MelĆ£o, MSc FDA to Review EMD Serono’s New Request for Approval of Cladribine for Treating Relapsing MS Seven years after it first denied the request, the U.S. Food and Drug Administration accepted for review EMD Seronoās resubmitted New Drug Application (NDA) for cladribine tabletsĀ (brand name Mavenclad) as a treatment for patients with relapsing forms of multiple sclerosis (MS). The regulatory agency agreed EMD…
July 27, 2018 News by Joana Carvalho, PhD Cladribine Added to Interferon-beta Seen to Lower Relapses in Active MS, But Safety Questioned 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 developĀ secondary progressive MS. Despite the growing number of treatment options ā including disease-modifying therapies ā 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-betaĀ 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 wasĀ developed byĀ EMD Serono (Merck KGaA outside the U.S. and Canada) and approved in the European Union using theĀ brand name MavencladĀ (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 usingĀ Rebif (marketed by EMD Serono), Avonex (byĀ Biogen), and Betaseron/Betaferon (byĀ 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) ā namely, the number of new brain and spinal cord lesions. However, almost half of patients in this treatment group developed lymphopenia, a conditionĀ 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.
July 17, 2018 News by Alice MelĆ£o, MSc Progressive MS Patients with Considerable Disability Ably Treated with Cladribine, UK Case Study Reports Cladridine may be effective in preventingĀ disability progression and reducing damage to nerve cells in people withĀ 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…
June 22, 2018 News by Patricia Inacio, PhD #EAN2018 – MavencladĀ Greatly Reduces Risk of RRMS Relapse, Analysis Finds New retrospective analysis of the Phase 3 CLARITY study (NCT00213135)Ā shows that treatment with MavencladĀ (cladribine tablets) improved annualized relapse rate and magnetic resonance imaging (MRI) outcomes in patients with relapsing-remitting multiple sclerosis (RRMS), regardless of their age. Moreover, the effectiveness of Mavenclad was comparable to five standard therapies…