Novartis’ migraine drug Aimovig (erenumab) has been on the market in the EU and Switzerland since November 2018. Now IQWiG indicates a considerable added benefit for certain patients.
With erenumab, the first monoclonal antibody in the EU for migraine prophylaxis has come onto the market. It is approved for adults with at least four or more migraine days per month, so-called episodic migraines. In an early benefit assessment, the Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether erenumab offers an additional benefit. The manufacturer Novartis had only presented the data for episodic migraine, but not for chronic migraine. However, since this classification is based solely on the number of days in pain and the boundaries between episodic and chronic migraine are blurred, IQWIG sees the indication of a considerable added benefit as not limited to episodic migraine. This is another step towards a blockbuster drug for Novartis. Now the G-BA has to make a final decision on the extent of the additional benefit.
Erenumab is directed against the calcitonin gene-related peptide (CGRP) receptor and, as a human antibody, prevents the action of the neuropeptide. The drug must be injected once a month with a pen, which the patient can do himself after proper training. Novartis developed the full human antibody with the US biotech company Amgen. It was the first monoclonal antibody marketed in the EU for migraine prophylaxis. The pipeline is now well filled with CGRP antibodies: In September, the drug manufacturer Ely Lilly received the green light from the EMA for galcanezumab (Emgality), Teva’s application for approval for fremanzumab (Ajovy) has also already been accepted by the EMA, and eptinezumab from Alder BioPharmaceuticals is currently underway another phase III study.
According to the Stiftung Warentest, 10 to 15 percent of people in Germany suffer from migraines more or less regularly. However, the foundation is cautious about migraine prophylaxis with the new “syringes against migraine”. There are no direct comparative studies, and the safety profile is still incomplete. In the studies, erenumab proved to be well tolerated and scores with better tolerability than previous prophylactics. However, side effects that occur less frequently can only be detected over the years with widespread use. Data on long-term use should be particularly important for patients with vascular diseases, since CGRP also has a protective function in the cardiovascular system. In the pivotal studies, subjects used erenumab for 12 or 24 weeks.