EMA Recommends Approval of Migraine Biologic

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 FDA approval in the United States on May 17, 2018, and additional regulatory filings are underway with other health authorities worldwide. Novartis has created a patient access program for the drug to provide patients with safe and timely access in accordance with local health authority regulations and applicable laws in cases where the product is not or not yet available.

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 entered into a global collaborationin August 2015 to jointly develop and commercialize new treatments in the field of migraine and Alzheimer's disease (AD). The collaboration focuses on investigational Amgen drugs in the migraine field, including Aimovig and AMG 301 (an early phase drug candidate). 

In April 2017, the collaboration was expanded to include co-commercialization of Aimovig in the US. The companies are also collaborating in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in AD. The company’s lead candidate, CNP520, is in Phase III development. Further compounds from both companies' pre-clinical BACE inhibitor programs may be considered as follow-on molecules.

Source: EMA, Novartis