
EMA Recommends Approval of Migraine Biologic
EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.
On June 1, 2018, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorization for Aimovig (erenumab), a human monoclonal antibody therapy for preventing migraine. Aimovig belongs to a new class of medicines that works by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is said to be involved in migraine attacks, according to the agency.
Novartis Europharm has filed the marketing authorization application for Aimovig in Europe. If approved, Aimovig will be self-administered once every four weeks via an auto-injector pen, according to the company.
The CHMP opinion will now be sent to the European Commission for the adoption of a decision on a European Union (EU)-wide marketing authorization. The decision will be applicable to all 28 EU member states plus Iceland, Norway, and Liechtenstein. Once a marketing authorization has been granted, decisions about price and reimbursement will take place at the level of each EU member state, taking into account the potential role/use of the therapy in the context of the national health system of that country.
The drug received
Under a 2015 collaboration with Amgen, Novartis and Amgen are co-commercializing Aimovig in the US. In addition, Amgen has exclusive commercialization rights to the drug in Japan, and Novartis has exclusive rights to commercialize in the rest of the world.
The companies
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