Aimovig

Aimovig is indicated for the prophylaxis of migraine in adults who experience at least 4 migraine days per month. The marketing authorization application was submitted on 23 May 2017, and a CHMP positive opinion was issued on 31 May 2018. Accelerated assessment status was not granted. The finished product has a shelf-life of 24 months and should be stored at 2°C to 8°C, with a maximum short-term storage temperature of 25°C for 14 days.

In clinical trials, Aimovig demonstrated a statistically significant reduction in mean monthly migraine days from baseline and a statistically significant responder rate (>=50% reduction in monthly migraine days from baseline). The change from baseline in monthly migraine days (LSM estimate) ranged from -4.18 to -6.64. The MMD responder rate (>=50% reduction) ranged from 23.5% to 41.2%. The difference in LSM for monthly migraine days versus placebo was -2.46 and -2.45. The adjusted odds ratio for MMD responder rate versus placebo ranged from 2.18 to 2.34. Additionally, there was a change from baseline in monthly acute migraine-specific medication treatment days (LSM estimate) ranging from -1.58 to -4.13, with a difference in LSM for acute medication days versus placebo of -1.86.

Safety findings included an incidence of binding antibodies against erenumab-aooe ranging from 15.8% to 17.9%, and neutralizing antibodies against erenumab-aooe at 0.5%. The incidence of anti-drug antibodies (ADAs) ranged from 2.6% to 17.9% across different doses and studies. The serious treatment-emergent adverse events incidence rate was 4.3 to 4.7 per 100 subject-years.