Marketing authorisation recommended for anti-migraine drug erenumab
The CHMP has recently issued a positive opinion, recommending the granting of a marketing authorisation for erenumab (Aimovig) for the prevention of migraine.
Erenumab is a monoclonal antibody that blocks calcitonin gene-related peptide (CGRP) receptors. CGRP is thought to have an important role in migraine pathophysiology through the transmission of pain signals, and erenumab is the first migraine treatment to specifically target this pathway. Erenumab is administered by monthly subcutaneous injection and can be self-administered at home using an auto-injector.
If marketing authorisation is granted by the European Commission, erenumab will be indicated for the prophylaxis of migraine in adults who have at least four migraine days per month; studies indicate that just over a third of adults with migraine will be eligible.
The efficacy and safety of erenumab has been assessed in clinical trials involving a total of 2600 patients with episodic or chronic migraine (including ARISE, STRIVE and LIBERTY). These trials have shown that erenumab 70–140mg can reduce the mean number of monthly migraine days compared with placebo, with significantly more patients taking erenumab achieving a 50% or greater reduction in monthly migraine days. The most common side-effects are injection-site reactions, constipation, muscle spasms and pruritus.
NICE has already begun a technology appraisal for erenumab, with publication expected in January 2019.