Regulatory Decision Summary for Aimovig

Aimovig (erenumab injection) is authorized in Canada for the prevention of migraine in adults who have at least 4 migraine days per month. The recommended dose of Aimovig is 70 mg administered once monthly. For patients that may benefit from a higher dose of Aimovig, a dose of 140 mg once monthly is also authorized. Patients prescribed the 140 mg dose of Aimovig currently require two consecutive s.c. injections of 1 mL with the authorized 70 mg/mL strength.

Study 20160349 was conducted to seek authorization of a new 140 mg/mL strength of Aimovig by assessing the relative bioavailability of two strengths of erenumab (70 mg/mL and 140 mg/mL) in healthy adult volunteers. The 140 mg/mL and 70 mg/mL strengths of erenumab were shown to be bioequivalent when administering a subcutaneous (s.c.) dose of 140 mg. Analyses of the primary endpoints (AUC_last, AUC_inf, and C_max) all indicated that there was no meaningful difference in exposure between the authorized 70 mg/mL strength and the new 140 mg/mL strength.

As this was a single-dose study, the safety findings observed in this study may not be generalizable to clinical practice; however, the safety profile of erenumab observed in this study was similar to the already well-established safety profile of Aimovig in adults who have at least 4 migraine days per month. No new or unexpected safety findings were observed that would alter the overall safety profile.

This submission provides PK and safety data supporting the use of a 140 mg/mL strength of Aimovig for patients prescribed the 140 mg dose. The 140 mg/mL strength of Aimovig allows for the administration of a 140 mg dose via a single 1 mL injection, rather than 2 separate 1 mL injections of 70 mg/mL.

No changes to the currently authorized indication are proposed in this SNDS and the benefit/risk profile of Aimovig remains favourable for the prevention of migraines in adults who have at least 4 migraine days per month.