Europe

June 25, 2024 News by Andrea Lobo, PhD

Subcutaneous Ocrevus approved in EU for relapsing MS, PPMS

The European Commission has approved a subcutaneous, or under-the-skin, formulation of Ocrevus (ocrelizumab) to treat adults with multiple sclerosis (MS). The approval makes the new formulation available in the European Union for the same indications as the original intravenous (into-the-vein) formulation, which is available to people with relapsing…

September 20, 2021 News by Marisa Wexler, MS

Vumerity Recommended for EU Approval as RRMS Treatment

A committee of the European Medicines Agency is recommending that Vumerity (diroximel fumarate) be approved as an oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…

March 30, 2021 News by Marta Figueiredo, PhD

Kesimpta Approved in EU as At-home Injectable Therapy for Relapsing MS

The European Commission has approved Novartis’ Kesimpta (ofatumumab) as the first self-administered, at-home B-cell-targeting therapy for adults with relapsing forms of multiple sclerosis (MS) and active disease. Active disease in these forms, which include clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS),…

April 14, 2020 News by Marta Figueiredo, PhD

Ocrevus Use Still Growing in Europe But Challenges on Horizon, Spherix Reports

Prescriptions of Roche’s Ocrevus (ocrelizumab) among multiple sclerosis (MS) patients initiating or switching a disease-modifying therapy (DMT) continue to rise in Europe, according to a survey conducted by Spherix Global Insights. Ocrevus, an anti-CD20 monoclonal antibody administered directly into a vein, was approved in the European Union to treat active forms…

November 6, 2019 News by Alice Melão, MSc

European 3TR Project Unites Experts in Effort to Make Treatment More Personal and Effective

A new public-private initiative brings academic and industry researchers from 15 European countries together in a large-scale effort to understand differences and commonalities in seven immune-mediated and inflammatory diseases, including multiple sclerosis, so to better predict a patient’s likely response to treatment and likely disease progression. The project, called 3TR…

January 15, 2018 News by Patricia Silva, PhD

European Commission Approves Ocrevus to Treat RRMS, PPMS Throughout EU

The European Commission has approved Roche’s Ocrevus (ocrelizumab) for both relapsing-remitting multiple sclerosis (RRMS) and primary-progressive multiple sclerosis (PPMS) across the 28-member European Union. The commission’s move —  nearly 10 months after the U.S. Food and Drug Administration (FDA) approved Ocrevus in March 2017 — makes it the first approved PPMS…

September 29, 2017 News by Patricia Silva, PhD

Switzerland First in Europe to Approve Ocrevus for Relapsing and Primary Progressive MS

Swiss regulatory authorities approved Ocrevus as a treatment for primary progressive and relapsing forms of multiple sclerosis on Sept. 28, making it the first approval of the drug in a European country. Since Switzerland is not part of the European Union, the approval will not affect the drug's regulatory status in other European countries. So far, the Roche/Genentech drug Ocrevus has been approved in North America, South America, the Middle East, Ukraine, and Australia. Like other countries where Ocrevus has been approved, it's the first drug OK'd in Switzerland for primary progressive MS, a form of the disease where disability moves forward relentlessly. And, as in other countries, the treatment option is equally appreciated among patients with relapsing types of MS. Ocrevus — an antibody that targets B-cells with the surface factor CD20 — was studied in two large Phase 3 trials in patients with relapsing MS called OPERA I and OPERA II (NCT01247324 and NCT01412333). Another trial, called ORATORIO (NCT01194570), is focused on people with primary progressive disease. The trials showed that the treatment significantly reduced disease activity and prevented progression in both patient groups. Researchers compared Ocrevus to Rebif (high-dose interferon beta-1a) in relapsing MS and to a placebo in primary progressive MS. Scientists also consider the drug to have a good safety profile. The most common side effects during the trials were mild-to-moderate infusion reactions and upper respiratory tract infections. Since its approval, researchers also have concluded that the treatment is less expensive than interferon. Ocrevus was approved in the U.S. on March 28, 2017. In the months that followed, many patients were concerned about the trial findings of more cancer cases in the treated, compared to control, groups. Since then, an increased risk of cancer with Ocrevus has not been confirmed, and researchers underscore that it is instead the coincidental and unusual circumstance that there were no cancer cases in the control group that created the imbalance. The European Medicines Agency is still processing the marketing application for Ocrevus. Roche reports that the company has filed marketing applications in more than 50 countries worldwide.

July 19, 2017 News by Janet Stewart, MSc

Costs Associated with Multiple Sclerosis Rise as Severity of Disease Increases, European Study Shows

Costs associated with multiple sclerosis increase as the disease worsens, according to a study of more than 16,000 patients in 16 European countries. The study, “New insights into the burden and costs of multiple sclerosis in Europe,” was published in the Multiple Sclerosis Journal. Researchers obtained their information from patient self-reporting. Patients used the Kurtzke's Expanded Disability Status Scale (EDSS) to assess the severity of their disease. They also reported on their quality of life and their resource use. Patients were divided into three categories. Those with a score between 0 and 3 on the EDSS scale were deemed to have a mild disease. The disease of those with scores of 4 to 6.5 was considered moderate. And the disease of those with scores of 7 to 9 was classified as severe. Patients assessed their health-related quality of life with the EuroQol Five Dimensions questionnaire. The average age of the 16,808 participants was 51 and a half years old. The work capacity of MS patients dropped from 82 percent of a healthy person's to 8 percent as the severity of the disease increased, researchers said. Patients' quality of life scores were about the same as those seen in the general population when they had a mild disease. But they plunged to less than zero when their disease became severe. The mean annual cost of having a mild form of MS was 22,800 euros, or around $26,300, researchers reported. The cost of having a moderate disease was 37,100 euros, or about $42,800. And the cost of a severe disease was 57,500 euros, or $66,340. Healthcare accounted for 68 percent of total costs with a mild disease, 47 percent with a moderate disease, and 26 percent for a severe disease. "Costs are dependent on the availability, use and price of services and on disease severity," the researchers wrote. "Costs were related to disease severity" in all countries "and were dominated by production losses, non-healthcare costs and DMTs," or disease-modifying therapies. Those therapies may be a key reason why the highest percentage of healthcare costs occurred in patients with a mild disease, researchers said. Doctors prescribe a lot of DMTs to this group. Other factors related to the high percentage were that many patients with mild diseases are still able to work -- meaning they incur fewer production-loss costs -- and this group requires fewer community services. As MS becomes more severe, patients' production losses rise, and they use more community services. "The intensity of healthcare service use varied widely across the countries," researchers wrote. "This reflects differences in healthcare organization, medical traditions, ease of access and – most importantly – availability of given services." Researchers also assessed patients' levels of fatigue and cognitive difficulties. Ninety-five percent reported fatigue, and 71 percent cognitive difficulties. Fatigue and cognitive difficulties had significant impacts on quality of life scores, researchers said.

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