European Medicines Agency

The European Medicines Agency (EMA) has agreed to review a request to approve Polpharma Biologics‘ biosimilar natalizumab for the treatment of multiple sclerosis (MS). This marks the first time the regulatory agency accepted a marketing authorization application for a biosimilar of Tysabri, an approved MS treatment. “The acceptance…

Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will review Novartis‘ applications seeking regulatory approval of ofatumumab, an investigational B-cell therapy for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Novartis’ applications for ofatumumab — which has the…

Seven months after starting a safety review of Lemtrada (alemtuzumab), the Pharmacovigilance Risk…

If necessary, women with relapsing multiple sclerosis can continue treatments based on interferon beta while pregnant and breastfeeding, according to an updated recommendation by an office of the European Medicines Agency (EMA). Interferon beta-based treatments are a mainstay of approved MS therapies. Three specific treatments were mentioned in press…

The European Medicines Agency (EMA) is reviewing safety data for Sanofi Genzyme‘s Lemtrada (alemtuzumab) following new reports of serious treatment side effects. Lemtrada is a humanized monoclonal antibody used to slow disease progression in adult patients with relapsing-remitting multiple sclerosis (RRMS). It works by blocking the activity of…

A review of data concerning the multiple sclerosis (MS) medicine Zinbryta (daclizumab) confirmed its association with the risk of developing severe and potentially fatal immune reactions in the brain, liver and other organs, according to the European Medicines Agency’s (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC). Zinbryta was authorized…

The European Medicines Agency has restricted the use of Zinbryta (daclizumab) for relapsing multiple sclerosis after reports of patients experiencing severe liver damage and one dying of liver disease. The temporary order restricts Zinbryta to European Union patients with a highly active disease who have failed to respond to…

American patient groups and neurologists have clearly been giving Ocrevus (ocrelizumab) plenty of attention since news of its approval landed, as a sweep of U.S. reaction to the FDA’s decision showed. But what is happening elsewhere in regard to this first treatment for both primary progressive and relapsing multiple sclerosis (MS)?…

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…

The U.S. Food and Drug Administration (FDA) is giving priority review to a request to approve Ocrevus (ocrelizumab) as a treatment for both forms of multiple sclerosis, the drug’s developer, Genentech, announced. If the company’s Biologics License Application (BLA) is approved, Ocrevus will become the first drug able to treat patients with either relapsing or…

Biogen, announced that TYSABRI, a drug developed to treat people with multiple sclerosis (MS) has received a positive opinion from the European Medicine Agency (EMA) recommending its approval to be used in people with elapsing-remitting multiple sclerosis (RRMS).

The European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC), responsible for assessing and monitoring safety issues for human medicines, completed a review on the risk for progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients treated with the medicine Tysabri (natalizumab). The issued guidelines have the objective of minimizing patients’ risk.