Novartis announced that the European Commission (EC) approved Aimovig® (erenumab) for the prevention of migraine in adults experiencing four or more migraine days per month.
Aimovig is the first and only treatment specifically designed for migraine prevention to be approved in the European Union, Switzerland, the US and Australia. It works by blocking a receptor called the calcitonin gene-related peptide receptor (CGRP-R) which plays a critical role in mediating the incapacitating pain of migraine. In the extensive clinical program of 2,600 patients, those on Aimovig experienced significant reductions in their number of migraine days per month, with a safety and tolerability profile similar to placebo. Aimovig can be self-administered or administered by another trained person every four weeks with the SureClick autoinjector pen, an established device commonly used for a range of different conditions.
Aimovig showed efficacy even in a difficult-to-treat population. It is the only CGRP-R pathway therapy specifically studied in patients who had failed on two to four previous treatments commonly used for migraine prevention. Furthermore, in an interim analysis from a five year open label extension (OLE) in episodic migraine, it was demonstrated that more than one in four (26%), patients taking Aimovig 70 mg, who were still enrolled and assessed for migraine over month fifteen, were completely migraine free.
A post-approval access program has been opened to provide Aimovig in countries where the local regulations allow provision of unapproved or yet to be reimbursed therapies. Support programs are also being developed for eligible patients in line with local regulations that include personalized services, information and resources to support them as they begin their treatment with Aimovig.
The EMA decision is applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein. Aimovig received U.S. FDA approval for the preventive treatment of migraine in adults on May 17, 2018. Aimovig received Swissmedic approval in Switzerland on July 13, 2018 and Australian TGA registration on July 3, 2018. Additional regulatory filings are underway with other health authorities worldwide.