Merck

A new collaboration between ModeX Therapeutics and Merck, known as MSD outside North America, is expected to advance the development of ModeX’s MDX-2201, an investigational vaccine targeting the Epstein-Barr virus (EBV). A history of infection with EBV — known for causing infectious mononucleosis, or mono, and certain…

MyHealthTeams and EMD Serono have teamed up to launch the Treatment and Adherence Resource Center, a new informational tool within the MyMSTeam social network for people living with multiple sclerosis (MS). The new resource center is geared toward educating MS patients about the importance of starting…

BioMed X announced a new collaboration with Merck to create a joint research group to investigate the role of the intestinal epithelial barrier in the development and progression of autoimmune diseases, including multiple sclerosis (MS). The intestinal epithelial barrier is a physical border between the gut and the rest…

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…

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…

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…

Australia was one of the first countries to approve the use of Mavenclad (cladribine tablets, 10 mg) to treat patients with highly active relapsing-remitting multiple sclerosis (RRMS). Now, the country’s government has taken another step to ensure this 20-day course treatment is available to the largest number possible of people affected by the disease. Australia’s Prime Minister, Hon. Scott Morrison MP, announced that Merck KGaA’s therapy was included on the Pharmaceutical Benefits Scheme (PBS) listing effective Jan. 1. This will make Mavenclad affordable for about 6,200 patients each year who are already accessing PBS-subsidized medicines for MS. (Of note, Merck KGaA is known as EMD Serono in the U.S. and Canada.) This was made possible by the joint effort of MS Australia, MS Research Australia, clinicians and members of the MS community who, after successive submissions, achieved a positive recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) to list Mavenclad on PBS as a treatment for RRMS. Australia's government will cover almost all costs of Mavenclad, which will mean that patients will have to pay only $40.30 per prescription, or $6.50 for concessional patients. “Thanks to our strong economic management, we’ve ensured that every new, essential medicine recommended for listing by the Pharmaceutical Benefits Advisory Committee receives government subsidy to make it affordable for all Australians,” the Prime Minister said in a press release. Mavenclad was developed to target immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. To be taken for a maximum of 20 days over two years, the oral drug has shown it helps MS patients remain relapse-free for up to four years, while supporting the “reset” of the immune system. Australia's regulatory agency decided to approve Mavenclad based on the findings of a number of clinical trials, including the Phase 3 CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537), and ORACLE-MS (NCT00725985) studies, as well as the Phase 2 trial ONWARD study (NCT00436826), and the long-term PREMIERE (NCT01013350) trials. These clinical studies involved more than 2,700 RRMS patients, some of whom were followed for more than 10 years. Overall, the trials showed that Mavenclad significantly reduced relapse rates, disability progression, and brain atrophy. Doctors recommend the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments.

Patients with relapsing-remitting multiple sclerosis (RRMS) on Rebif (interferon beta 1-a), using the RebiSmart autoinjector, have high treatment adherence, despite seasonal weather or temperature fluctuations, as well as fewer relapses over one year, a real-world study reports. The study, “Seasonal adherence to, and effectiveness of,…

To more widely recognize and help those caring for people with multiple sclerosis (MS) and other chronic diseases, Merck KGaA (known in the U.S. and Canada as EMD Serono) is expanding its global Embracing Carers program to include Brazil and possibly China. “Caregivers are a hidden pillar within the…

Thousands of scientists, doctors, pharmaceutical company executives and others — representing about 100 countries — will meet for three days to discuss and debate the latest developments in multiple sclerosis (MS) at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, best known as…

Genentech‘s Ocrevus (ocrelizumab), approved in March 2017, has fueled a sea change in the treatment of multiple sclerosis (MS) patients in the U.S., leading to an increased interest in disease-modifying therapies (DMTs) for progressive forms of MS. Now, other potential treatment choices for progressive MS forms will likely…

New retrospective analysis of the Phase 3 CLARITY study (NCT00213135) shows that treatment with Mavenclad (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…

Girls given the quadrivalent human papillomavirus (HPV4) vaccination, commercialized as Gardasil, showed no increased risk of developing autoimmune diseases like multiple sclerosis (MS), according to a new Canadian study. The time since vaccination and the number of vaccine doses given also did not correlate with diagnoses of such disorders, supporting…

Mavenclad Effective in Treating Highly Active MS, New CLARITY Analysis Shows Mavenclad isn’t approved for use in the U.S. but it is approved in Canada, Europe, and other parts of the world. Here’s another positive study of the therapy. Hopefully, it won’t be much longer before Americans…

Cladribine treatment leads to a selective depletion of memory B-cells in patients with relapsing-remitting multiple sclerosis (RRMS), researchers report. The results are in the presentation “Cladribine for the Effective Control of Multiple Sclerosis via Memory B Cell Depletion” being given Friday, the final day of the 2018 Annual Meeting of the …

Merck KGaA’s evobrutinib led to significant reductions in relapsing multiple sclerosis patients’ brain and spinal cord lesions, compared with a placebo, a Phase 2b clinical trial showed. Researchers measured the number of lesions at weeks 12, 16, 20 and 24. Evobrutinib, also known as M2951, is an oral inhibitor of…

Argentina has become the first country in Latin America to approve Mavenclad (cladribine) as a treatment for adults with highly active relapsing multiple sclerosis. The Argentinian Administration of Medicines, Food and Medical Technology's approval covered Merck’s cladribine tablet formulation. Merck expects to make the treatment available in the country in the next few months. Mavenclad has already been approved in Canada, Australia, Israel, and Europe. Merck is seeking approval in the United States and other countries. "Having a new MS treatment approved in Argentina is very motivating," Dr. Jorge Correale of the Institute for Neurological Research Dr. Raúl Carrea said in a press release. "Mavenclad allows the patient's immune system to go through a selective immune reconstitution, similar to a reset, and the treatment mechanism is simple because it does not require frequent administration or monitoring," said Correale, head of the institute's neuroimmunology and demyelinating diseases department. Mavenclad is designed to target the immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. With a maximum of 20 days' treatment over two years, the oral drug promotes long-term inhibition of harmful immune cells, reconstituting the immune system. MS is an autoimmune disease, or one in which the immune system attacks normal tissue as well as invadors. Argentine regulators based their approval on the results of five clinical trials. These were the Phase 3 CLARITY, CLARITY EXTENSION, and ORACLE-MS studies, the Phase 2 ONWARD study, and the long-term PREMIERE study. These trials involved more than 2,700 patients with relapsing MS, some of whom researchers followed for more than 10 years. The trials showed that Mavenclad can significantly reduce MS relapse rates, disability progression and brain atrophy. The treatment is recommended for patients who fail to respond adequately, or are unable to tolerate, other therapies. "We are pleased the Argentinian Administration of Medicines, Food and Medical Technology has approved Mavenclad," said Rehan Verjee, the chief marketing and strategy officer of Merck's biopharma business. "Our goal is to ensure fast access to patients who may benefit from this innovative therapy, and we will be working with payers on obtaining reimbursement as a next step."

Australia has approved a shorter treatment regimen of Merck’s Mavenclad for relapsing-remitting multiple sclerosis. The Therapeutic Goods Administration authorized 20-day courses of the cladribine tablet form of the medication once a year for two years. The regimen reduces relapse rates and the progression of the disease for up to four years, Merck said. The new approval came after Merck submitted additional clinical trial findings on the therapy. Health Canada and the European Commission approved Mavenclad earlier this year. Merck continues to seek its regulatory approval in the United States and other countries. "Mavenclad will be a welcomed treatment option for patients with the relapsing-remitting form of MS,” Bill Carroll, clinical professor of neurology at the University of Western Australia and the Perron Institute, said in a press release. “As an oral therapy taken in two short courses over a two-year period, Mavenclad will be convenient for all eligible patients in Australia, including those who may not live close to their treating healthcare professional," added Carrol, a neurology consultant at the Sir Charles Gairdner Hospital as well as president-elect of the World Federation of Neurology. Mavenclad targets immune cells that trigger relapsing MS. Multiple sclerosis is an autoimmune disease, or one in which the immune system attacks healthy cells. Mavenclad inhibits harmful immune T- and B-cells without suppressing the entire immune system. Australia based its approval of the drug on the findings of a number of clinical trials, including the Phase 3 CLARITY, CLARITY EXTENSION and ORACLE-MS studies, the Phase 2 trial ONWARD study, and the long-term PREMIERE studies. The trials involved more than 2,700 RRMS patients, some of whom were followed more than 10 years. The trials showed that Mavenclad can significantly reduce relapse rates, disability progression and brain atrophy. Doctors recommended the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments. "We are pleased the Therapeutic Goods Administration has updated the product Information for Mavenclad in Australia to reflect additional clinical data," said Simon Sturge, chief operating officer of Merck's biopharma business. "Our next step is to work closely with the Australian government to bring this treatment advance to patients as quickly as possible."

Canadians with relapsing-remitting multiple sclerosis can now receive Merck’s Mavenclad, now that Health Canada has approved Mavenclad as a therapy to reduce the frequency of MS exacerbations and delay disease progression. Merck expects the drug to be commercially available by early January 2018 throughout Canada, which has the world's highest MS rate. This follows the drug’s approval by the European Commission in August, making Mavenclad Europe's first approved highly efficient, oral short-course therapy for relapsing MS. Merck said it would seek regulatory approval of Mavenclad in other countries, including the United States. Mavenclad was designed to selectively target immune cells that trigger relapsing MS, while resetting the immune system. With two annual courses of treatment for a maximum of 20 days over two years, the oral drug promotes long-term inhibition of harmful immune T- and B-cells, without continuous suppression of the immune system. Researchers evaluated Mavenclad in five clinical trials: Phase 3 trials CLARITY, CLARITY EXTENSION and ORACLE-MS; the Phase 2 trial ONWARD study ; and the long-term study PREMIERE. These involved more than 2,700 RRMS patients, some of whom were observed for more than 10 years. Clinical data showed that Mavenclad can significantly reduce disability progression, annualized relapse rates and brain atrophy. The treatment is generally recommended for patients who failed to respond adequately, or are unable to tolerate, one or more MS therapies.

Merck’s Mavenclad (cladribine tablets) is now a recommended treatment for British adults with highly active multiple sclerosis (MS), following the issuance of a final appraisal determination by the country’s National Institute for Health and Clinical Excellence (NICE). The therapy — given at a dosage of 10 mg — received the…

Research teams from Canada, Portugal and the United States, each with projects focused on predicting and defining characteristics of multiple sclerosis (MS) , will share this year’s 1 million euro ($1,165,700) Grant for Multiple Sclerosis Innovation (GMSI), announced by Merck at the 7th Joint ECTRIMS-ACTRIMS meeting in Paris, France,…

Mavenclad (cladribine tablets), an oral therapy by Merck that’s approved to treat people with active relapsing multiple sclerosis in much of Europe, is a “smart therapy” that is showing real and long-term benefit after a short treatment course, said Gavin Giovannoni, chair of neurology at Barts and The London School of Medicine…

Mavenclad reduced multiple sclerosis relapses by 79 percent and prevented the development of additional inflammatory lesions in 84 percent of patients with high disease activity, according to presentations Merck KGaA will make in Paris next week. The company will share a host of new data at the 7th Joint ECTRIMS-ACTRIMS…

Merck’s Mavenclad tablets significantly improve quality of life among relapsing multiple sclerosis patients while reducing the number of relapses, according to new analyses of previously unpublished data from clinical trials assessing the drug. This new data, published in the Multiple Sclerosis Journal, come just as the European Commission ponders whether to approve the once- rejected therapy to treat relapsing forms of MS. Its decision is expected later this month, seven years after a perceived increased of cancer risk led the European Medicines Agency (EMA) to block Mavenclad. In 2011, the U.S. Food and Drug Administration (FDA) rejected the medication, forcing its eventual withdrawal from the Australian and Russian markets, where it had already been licensed. For the study, researchers at Queen Mary University of London used data obtained from the EMA through a Freedom of Information request. They analyzed data from the Phase 3 CLARITY trial, which compared Mavenclad to placebo. The trial's 1,326 participants completed a quality-of-life questionnaire that focused on disease aspects such as mobility, self-care, usual activities, pain or discomfort, and anxiety. After two years, those on Mavenclad had significantly improved their quality of life compared to the control group, particularly in terms of self-care. Mavenclad also helped mobility, which might be related to its ability to prevent relapses and delay progression, researchers said. While researchers assessed quality of life using two different questionnaires, patients had only completed one in sufficient numbers to allow for a solid analysis. The other quality-of-life tool provided researchers with numerically positive results, but the low number of responses made the result difficult to interpret. This wasn't the first time QMUL researchers have contributed in this way to knowledge of Mavenclad in MS. In 2015, they used a Freedom of Information request to obtain data showing that Mavenclad was not related to increased cancer risk. “Cladribine seemed to have such excellent potential as a treatment for MS that we thought it was tragic the development program was shelved, and significant parts of the clinical trial data remained unpublished,” study leader Klaus Schmierer, a neurologist at both QMUL and Barts Health NHS Trust, said in a press release. “In addition to the drug being highly effective, well tolerated and safe as far as short-term studies can show, we now know it also improves patients’ quality of life. The new results seemed so clear, we felt it was extremely important to publish and share these data." Mavenclad has now been studied in some 2,700 patients with relapsing MS in the Phase 3 trials CLARITY, CLARITY EXTENSION, and ORACLE-MS, as well as the Phase 2 ONWARD trial, and the ongoing long-term study PREMIERE. The treatment differs from most other oral MS therapies in that a short treatment course — a maximum 20 days — triggered effects that were upheld for two years. Studies of Mavenclad’s mechanisms suggest the drug gets such results by resetting the immune system. In June 2017, the EMA's Committee for Medicinal Products for Human Use urged the European Commission to approve Mavenclad. Merck also plans to seek U.S. approval for its therapy and is now in talks with the FDA about Mavenclad's future.

New analyses of how Merck’s Mavenclad (cladribine tablets) act to treat relapsing multiple sclerosis (MS) give researchers an entirely new picture of immune processes leading to the disease. Data showed that the drug lowers both immune B-cells and, to a lesser degree, T-cells. But the numbers of both cell…

Merck’s cladribine tablets are now just one step away from obtaining European Union approval as a relapsing multiple sclerosis treatment. The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that the European Commission approve the tablets. “The positive opinion from the CHMP [the committee] is an extraordinary…

Cladribine tablets reduce the risk of disability progression and relapse in patients with relapsing multiple sclerosis (MS), the CLARITY clinical trial indicates. The treatment was also well-tolerated and had a good safety profile, according to a presentation at the Annual Meeting of the American Academy of Neurology (AAN) in Boston,…

EMD Soreno has recently published Phase 3 clinical data showing that Cladribine tablets reduced the annualized rate of brain volume loss (BVL, brain atrophy) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS). The study, “Reduced brain atrophy rates are associated with lower risk of disability progression…

Merck recently presented new efficacy data from its three Phase 3 clinical trials, showing that a relatively short course of treatment with Cladribine tablets led to long-term reductions in annualized relapse rate (ARR) in people with relapsing multiple sclerosis (RMS). The data were given in two oral presentation at the 32nd Congress of the…

Merck KGaA, Darmstadt, Germany recently announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) of the company’s investigational product Cladribine Tablets as a therapy for relapsing multiple sclerosis (RMS) in Europe. Cladribine is a synthetic antineoplastic agent able to suppress the immune system, causing relatively few…