Ajovy(fremanezumab)

Fremanezumab (Ajovy) is indicated for the treatment of episodic and chronic migraine in adults. Clinical trials demonstrated a reduction in monthly migraine days compared to placebo. For episodic migraine, monthly dosing of fremanezumab showed a 3-5 day reduction from baseline in primary endpoints, while the placebo group experienced a 2-day reduction. For chronic migraine, monthly dosing also resulted in a 3-5 day reduction from baseline in primary endpoints. Quarterly dosing of fremanezumab similarly showed a 3-5 day reduction from baseline in primary endpoints.

Specifically, the adjusted mean treatment difference in monthly average number of migraine days versus placebo was -1.8 days for fremanezumab 225/225/225 mg dosing and -1.3 days for fremanezumab 675 mg/placebo/placebo dosing. The proportion of patients with greater than 50% reduction in monthly average migraine days was 47.7% for fremanezumab 225/225/225 mg and 44.4% for fremanezumab 675 mg/placebo/placebo, compared to 27.9% for placebo.

Safety findings indicate that 65% of fremanezumab-treated patients experienced at least one adverse event, compared to 59% in the placebo group. Injection site pain was reported in 16% of men receiving fremanezumab. Discontinuation due to adverse events occurred in 2% of the placebo group. The marketing authorization application was submitted on January 12, 2018, and a positive CHMP opinion was issued on January 31, 2019.