December 22, 2023 News by Mary Chapman Generics of Tecfidera not available in Europe until at least 2025 The European Commission (EC) has withdrawn its marketing authorizations for generic versions of Tecfidera (dimethyl fumarate), an oral therapy approved in Europe for relapsing-remitting multiple sclerosis (RRMS). According toĀ Biogen, which developed and markets the brand-name medication, the decision ensures Biogen will have full data and marketing protection…
September 28, 2023 News by Andrea Lobo, PhD Tyruko, first Tysabri biosimilar, approved in Europe for RMMS The European Commission has approved Tyruko (natalizumab), the first biosimilar of Tysabri, for the treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS). The approval makes Tyruko available in the European Union for the same indication as its reference medicine. It also marks the first approval…
June 2, 2023 News by Marisa Wexler, MS Briumvi approved in Europe for active, relapsing forms of MS The European Commission has approved Briumvi (ublituximab) for the treatment of adults with relapsing forms of multiple sclerosis (MS) who have active disease, as defined by clinical or imaging features. The approval, which covers all member states in the European Union, as well as Iceland, Norway, and Liechtenstein,…
November 17, 2021 News by Marisa Wexler, MS Vumerity Approved for RRMS in European Union The oral medication Vumerity (diroximel fumarate) has been approved by the European Commission to treat adults with relapsing-remitting multiple sclerosis (RRMS). “This approval is a significant step forward in improving treatment adherence for people living with relapsing MS, which can make a meaningful difference on treatment…
June 21, 2021 News by Marisa Wexler, MS Oral Aubagio Approved in EU for Children With RRMS, Ages 10-17 The European Commission (EC) has approved Aubagio (teriflunomide) for the treatment of children and adolescents, ages 10 to 17, withĀ relapsing-remitting multiple sclerosis (RRMS). Aubagio, approved for adults with RRMS since 2013, is now the first oral therapy available as a first-line treatment for pediatric patients in the European…
May 25, 2021 News by Forest Ray PhD Ponvory Approved in EU for Active Relapsing Forms of MS The European Commission has approved PonvoryĀ (ponesimod) to treat adults with relapsing forms of multiple sclerosis (MS) and active disease, as defined by clinical or imaging features. The approval, which follows a recommendation from the Committee for Medicinal Products for Human Use in March, covers clinically isolated…
April 8, 2021 News by Marisa Wexler, MS Under-the-skin Injection of Tysabri Approved in Europe The European Commission (EC) has approved a new method to administer Tysabri (natalizumab) as a treatment for people with relapsing-remittingĀ multiple sclerosis (RRMS). This new delivery route involves a subcutaneous injection in which Tysabri is injected under the skin. Compared with the previously approved intravenous (into the bloodstream) formulation,…
May 27, 2020 News by Marisa Wexler, MS Zeposia Receives European Commission Approval for Adults with Active RRMS The European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) who have active disease based on clinical or imaging features. The EC decision follows a positive opinionĀ issued in March by the EuropeanĀ Committee for Medicinal Products for Human Use (CHMP).
November 30, 2018 News by Alice MelĆ£o, MSc Gilenya Now Approved in Europe to Treat Children, Adolescents with RRMS Gilenya (fingolimod) was approved by the European Commission as a treatment for children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS), Novartis announced. The therapy is already approved in Europe to treat RRMS patients 18 and older. With this newest decision, Gilenya has become…
November 14, 2017 News by Alice MelĆ£o, MSc Europe’s CHMP Urges Approval of Ocrevus in EU to Treat Relapsing, Primary Progressive MS Europeans with relapsing multiple sclerosis (MS) andĀ earlyĀ primary progressive MS are one step closer to accessingĀ Ocrevus, now that the European Medicines Agency has urged the European Union to approve the therapy. The positive opinion ā announced inĀ a press release issued Nov. 10 by the EMAās Committee for Medicinal Products for Human UseĀ ā is an intermediary step required in the regulatory pathway to allow patient access to a new drug. The European Commission will now make a final decision on whetherĀ OcrevusĀ should be granted marketing authorization in all 28 EU member states. This decision will take the CHMP recommendation into consideration. If approved, Ocrevus will become the first disease-modifying medicine available throughout Europe for patients with PPMS. Once this happens,Ā any decisions on price or insurance reimbursements will be the responsibility of each member state. OcrevusĀ wonĀ U.S. approval earlier this year. It was alsoĀ recentlyĀ approved in Switzerland for both relapsing MS and PPMS. Ocrevus is an anti-CD20 antibody developed by Genentech, a division ofĀ Roche. It blocks immune B-cells, preventing them from attacking nerve cells and their myelin protective sheath, as well as inhibiting other pro-inflammatory immune signals involved in MS. CHMP based its positive recommendation on data from three pivotal Phase 3 clinical trials: the OPERA I and II trials in relapsing MS patients, and the ORATORIO trial in PPMS patients. Results from the OPERA clinical studies demonstrated that treatment with Ocrevus for up to 96 weeks could reduce the annualized relapse rate by 46.4 percent compared with EMD Seronoās approved drug Rebif (interferon beta-1a) in relapsing MS patients. The ORATORIO trial showed that Ocrevus could reduce by 24 percent the risk of 12-week confirmed disability progression compared to placebo in PPMS patients. Data from the trial further supported the drug's therapeutic benefit in early-stage PPMS patients. Additional studies are warranted to better evaluate the therapeutic potential of Ocrevus for patients with more advanced stages of the disease. The most common treatment-associated adverse effects reported wee infusion-related reactions and infections.
July 7, 2016 News by Patricia Inacio, PhD Zinbryta (Daclizumab) Approved in Europe to Treat Relapsing MS Biogen and AbbVieĀ announced that the drug ZinbrytaĀ (daclizumab) has received marketing authorization by the European Commission, and is an approved treatment across most ofĀ Europe forĀ adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a self-administered, once monthly subcutaneous injection. āClinical data showed Zinbryta significantly reduced relapses, 24-week…
July 28, 2014 News by Patricia Silva, PhD Biogen Idec’s Injection Plegridy Approved in Europe to Treat RRMS The European Commission granted marketing authorization for the use of Plegridy, a drug developed by Biogen IdecĀ as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS),Ā the most common form of multiple sclerosis (MS). The approval comes at a time when…