Merck KGaA

Merck KGaA announced that evobrutinib, its oral candidate for relapsing multiple sclerosis (MS), was able to safely and significantly reduce active brain lesions over 24 weeks of treatment, according to results of a Phase 2 study sponsored by the company.

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…

Merck KGaA will present the latest advances made on several of its therapies aiming to treat multiple sclerosis (MS) at the 34th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS). The conference is taking place through Friday in Berlin. The company, known as…

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…

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…

An additional analysis of data from the CLARITY study confirmed the long-term benefits of treatment with Mavenclad (cladribine tablets) for patients with highly active relapsing forms of multiple sclerosis (MS). The post-hoc analysis, “Efficacy of Cladribine Tablets in high disease activity subgroups of patients…

The United Arab Emirates is the first country in the Middle East and Africa to approve Mavenclad (cladribine tablets) as a treatment for patients with highly active relapsing multiple sclerosis (MS) evidenced through imaging tests or clinical evaluation. The therapy is expected to become available once local regulatory…

Comobidities are common in multiple sclerosis (MS) patients in the U.S., with the most frequent being high cholesterol and blood pressure, followed by gastrointestinal disease, thyroid disease, and anxiety, a database analysis reports. But distinctions exist between the sexes, this claims analysis found. High cholesterol and blood pressure, as well as diabetes…

Mavenclad has become the multiple sclerosis therapy of choice for one in five neurologists in Germany and the United Kingdom, according to a Spherix Global Insights survey. Meanwhile, many European neurologists are looking forward to the continent's approval of Ocrevus, particularly as a treatment for primary progressive multiple sclerosis, or PPMS. The United States approved the therapy in March of 2017. European neurologists are using Mavenclad for both relapsing-remitting multiple sclerosis, or RRMS, and secondary progressive multiple sclerosis, SPMS. The report that Spherix issued on European neurologists' treatment choices is called "RealTime Dynamix: Multiple Sclerosis EU." It was based on a survey of 261 neurologists, who were asked about thei disease-modifying drugs they prescribed and the way they manage MS, according to a press release. The survey focused on Merck KGaA’s Mavenclad, which the European Union approved in August 2017, and Genentech’s Ocrevus, which the European Commission is expected to approve soon. The European Medicines Agency paved the way for approval by recommending its authorization earlier this month. Mavenclad is the first disease-modifying therapy that most of the patients who are on it have tried, according to the survey. Spherix analysts said this indicates that Mavenclad may expand the proportion of MS patients using disease-modifying drugs. But while Mavenclad’s label allows patients to use it as a first-line therapy, the survey revealed that many neurologists are not comfortable prescribing it as an initial treatment. This suggests that the Mavenclad-treated population may later include more patients who switched treatments, Spherix said. Mavenclad reduces MS relapses by resetting the immune system, studies have shown. Neurologists who prescribe it as a first-line treatment appear to endorse the idea of induction therapy. This approach involves more potent therapies being used from the onset of the disease. British neurologists in particular appear to favor the induction approach, the report revealed. Patients who had been on previous treatments have switched mainly from Copaxone (glatiramer acetate), interferons, or Novartis' Gilenya, the report showed. Many neurologists' lack of familiarity with Mavenclad may be limiting its use, the report said. It noted that two out of five neurologists had not received a detailed briefing on the drug, and more than one-third had not attended any launch activities. Limited market access was the second most common obstacle to Mavenclad prescription, the report indicated. Interestingly, those who had participated in Mavenclad launch activities said these consisted mostly of independent research or discussions with colleagues, rather than activities organized by Mavenclad’s developer Merck KGaA. Spherix’s survey was done just before the European Medicines Agency recommended Ocrevus' approval in mid-November. Even before the endorsement, the survey indicated, Ocrevus was by far the MS drug in development that most neurologists looked forward to using. The reasons, the neurologists said, were its beneficial effectiveness-safety profile, its new mechanism of action, the fact that it only needs to be given once every six months, and a treatment label that includes PPMS. It is the first disease-modifying drug ever approved for PPMS patients. Twice as many neurologists said they look forward to using Ocrevus as a first-line treatment for PPMS as those saying they wanted to use it as a first-line treatment for relapsing MS. And neurologists estimated that twice as many PPMS patients as RRMS patients are appropriate candidates for Ocrevus treatment. In a report in October about U.S. neurologists' treatment preferences, Spherix said those doctors estimated the number of PPMS Ocrevus candidates at three times that of RRMS patients. Nonetheless, about equally as many PPMS and RRMS patients had tried Ocrevus four months after its launch, the survey showed. The European situation may evolve in a similar manner, since the European Medicines Agency recommended a specific use of Ocrevus in PPMS patients. It specified that the drug be used in PPMS patients who show “imaging features characteristic of inflammatory activity." This makes it likely that only a subgroup of PPMS patients will receive the treatment. The use of Biogen's Tysabri, Gilenya, and Rituxan (rituximab), also made by Roche's Genentech subdivision, will be most impacted by Ocrevus' introduction. Despite this, neurologists believe rituximab's use will grow in the next six months, because Ocrevus is still not available, while lower-cost rituximab biosimilars are.

The 7th Joint ECTRIMS-ACTRIMS Meeting, taking place in Paris this month, is one of the largest scientific conferences focused solely on multiple sclerosis (MS), and the National Multiple Sclerosis Society will be among the many interested parties attending. To get a feeling for meeting highlights and presentations the…

Three-fourths of relapsing multiple sclerosis patients who took two short courses of Mavenclad over two years remained relapse-free for four years, according to newly published data from the medication's Phase 3 extension trial. Moreover, patients who took Mavenclad during the first two years and then a placebo for the next two years fared similarly to those who took Mavenclad for the entire four-year period. The European Commission on Aug. 25 approved Mavenclad — developed by Merck KGaA (known as EMD in North America) — to treat relapsing forms of MS in Europe. It based that approval on data from the Phase 3 CLARITY, CLARITY EXTENSION, and ORACLE-MS trials, as well as the Phase 2 ONWARD trial, and the ongoing long-term PREMIERE study. Besides showing the long-term impact of two short courses of Mavenclad — patients took tablets for a maximum of 20 days over two years — this latest study showed that continuing treatment into the third or fourth year offered no additional benefits. This finding supports Merck’s earlier studies, which suggested that Mavenclad resets the immune system. This is a stark contrast in treatment approach to most approved MS drugs which work by suppressing either T- or B- immune cells over the long term. Researchers also deemed safety to be similar in the two groups. Most adverse events were mild or moderate, and most patients who had their B-cells and T-cells depleted in the first part of the study had normal, or nearly normal, levels at the end of the extension. Shingles were most common in patients who received the highest cumulative dose of the drug, affecting 4.8 percent of participants. But in the remaining treatment groups, rates of the viral infection were similar at 1.1 to 2 percent, researchers said. Besides Merck's own studies, an independent study recently demonstrated that Mavenclad also improves patients’ quality of life. As such, the company plans to file regulatory approval for Mavenclad in the United States and elsewhere.

Apitope and Merck KGaA announced that they have entered into an exclusive agreement regarding ATX-MS-1467, a potential disease-modifying therapy for  multiple sclerosis (MS). Under its terms, Apitope will regain full global rights over ATX-MS-1467, as well as all clinical data related to the compound. In 2009, the company granted exclusive global rights to Merck KGaA to develop…

EMD Serono, the U.S. and Canadian subsidiary and biopharmaceutical business of Merck KGaA, focuses exclusively on specialty care. With expertise in fertility, endocrinology, oncology and neurology, the company is featuring several innovative products with therapeutic potential in the oncology, immuno-oncology, and immunology fields. Rebif (interferon beta-1a), EMD Serono’s therapy for patients with relapsing…

A scientist from the Oklahoma Medical Research Foundation (OMRF) is the recipient of 1 of only 5 Multiple Sclerosis Innovation grants from German biopharmaceutical company EMD Serono. Manu Nair, the foundation’s Vice President of Technology Ventures, said that this funding from a new collaborative relationship is a crucial step towards…

The nonprofit organization Accelerated Cure Project for Multiple Sclerosis is going to sponsor the launch of the Optimizing Treatment – Understanding Progression (OPT-UP) study in collaboration with biopharmaceutical company EMD Serono, Inc, a subsidiary of the german Merck KGaA. The study will enroll 2,500 MS…