July 30, 2018. The migraine immunotherapy with the active ingredient erenumab (Aimovig) can now also be sold in the EU. The US approval was initially given in May 2018, followed by approval in Switzerland in July. Now the EU Commission has also approved erenumab market access for the EU on July 30, 2018. On May 31, 2018, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) made a recommendation for the approval of erenumab (Aimovig) for the prophylaxis of migraine attacks. The drug was already approved by the US Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in the USA on May 17, 2018 (see this article ). Aimovig is available in the form of a solution for subcutaneous injection containing 70 mg. The active ingredient in Aimovig is erenumab. The effect occurs via binding to the calcitonin gene-related peptide (CGRP) receptor. Studies have shown that Aimovig can reduce the number of monthly migraine days. The most common side effects were injection site reactions and constipation.

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has now also published the indication text. Thereafter, Aimovig is indicated for the prevention of migraines in adults who experience at least 4 migraine days per month. The drug can therefore be used to prevent both episodic and chronic migraines.

The European Medicines Agency (EMA) has recommended that Aimovig can be prescribed by doctors who specialize in the diagnosis and treatment of migraines. Further details of the regulation will be published in all European languages ​​once the European Commission has granted approval.

In the next step, the European Commission had to evaluate the recommendation of the European Medicines Agency (EMA). This has now happened. It applies to all 28 member states of the European Union including Iceland, Norway and Lichtenstein. The drug is then expected to be available in Germany in August/September 2018. The manufacturing company has created a patient access program in the USA. This stipulates that patients can receive the medication free of charge for two months or the co-payment is capped at $5 per month.

The Swiss Institute of Medicines Swissmedic approved Aimovig for migraine prevention in mid-July 2018 and it is already available in Switzerland.

Summary of the EMA recommendation on erenumab
US product information

The figures show the summaries of results from the erenumab clinical trial program on which the approval is based. A total of over 3,000 migraine patients took part in the clinical studies. The long-term program currently includes data on safety and tolerability over 5 years. The safety profile during this period was comparable to that of placebo treatment.