February 29, 2024 News by Andrea Lobo, PhD Briumvi for relapsing MS now available for patients in Europe Briumvi (ublituximab-xiiy), an approved treatment for relapsing forms of multiple sclerosis (MS), is now available to patients in Europe, where itās being marketed by Neuraxpharm. The infusion therapy, developed by TG Therapeutics, was first launched in Germany, with additional rollouts following in other European countries. Under…
July 25, 2023 News by Marisa Wexler, MS PB006, biosimilar of Tysabri, favored for approval in European Union The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended that PB006, a biosimilar version of Tysabri (natalizumab), be approved to treat adults with highly active relapsing-remitting multiple sclerosis (RRMS). The recommendation comes about a year after the regulatory agency…
April 4, 2023 News by Margarida Maia, PhD CHMP favors Briumvi for approval to treat relapsing forms of MS in EU An arm of the European Medicines Agency favors the approval of Briumvi (ublituximab) to treat adults with active, relapsing forms of multiple sclerosis (MS) across theĀ European Union (EU). The Committee for Medicinal Products for Human Use (CHMP) opinion is based on data from twin Phase 3 trials,…
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…
March 30, 2020 News by Marta Figueiredo, PhD CHMP Favors Zeposia (Ozanimod) as Oral Treatment for Active RRMS in EU TheĀ Committee for Medicinal Products for Human UseĀ (CHMP) has recommended Zeposia (ozanimod) oral capsules to be approved in the European Union (EU) to treat adults with active relapsing-remitting multiple sclerosis (RRMS). Opinions released by CHMP, an arm of theĀ European Medicines AgencyĀ (EMA), are generally accepted by the European Commission,…
November 15, 2019 News by Grace Frank CHMP Favors Mayzent as Oral Treatment Specifically for Active SPMS Patients in EU The Committee for Medicinal Products for Human Use (CHMP) issued an opinion supporting MayzentĀ (siponimod) as an oral treatment specifically for adults with active secondary progressive multiple sclerosisĀ (SPMS) in the European Union. Opinions released by CHMP, an arm of the European Medicines Agency (EMA), carry weight and are…
December 7, 2016 News by Patricia Silva, PhD Copaxone Use During Pregnancy by RMS Patients Now Possible in EU European users ofĀ Copaxone (glatiramer acetate injection, Teva Pharmaceutical) to treatĀ relapsing forms of multiple sclerosis (RMS) will no longer see a warning that the drug should not be used during pregnancy. A report assessing this change in the drug’sĀ marketing authorization within the European Union ā a process known as…