What is the efficacy of Ajovy (fremanezumab) for migraine prevention?

From the Guidelines

Ajovy (fremanezumab) is a strongly recommended preventive medication for episodic or chronic migraine, as evidenced by the 2024 clinical practice guideline for the management of headache 1. The efficacy of Ajovy for migraine prevention is well-established, with the most recent guideline recommending it as a first-line treatment option.

• Key benefits of Ajovy include its ability to reduce migraine frequency and severity, with some patients experiencing significant improvements within the first month of treatment.
• The medication is administered via subcutaneous injection, either monthly or quarterly, and is generally well-tolerated, with common side effects limited to injection site reactions.
• Serious side effects are rare, and Ajovy does not cause the weight gain, cognitive issues, or fatigue associated with some other migraine preventives, making it a suitable option for adults with both episodic and chronic migraines.
• Before starting Ajovy, patients should inform their doctor about allergies, pregnancy plans, and other medications, and insurance coverage should be verified, as the medication can be expensive without coverage.
• The guideline's strong recommendation for Ajovy is based on a review of the latest evidence, including studies demonstrating its efficacy and safety in preventing migraines 1.

From the FDA Drug Label

The efficacy of AJOVY was evaluated as a preventive treatment of episodic or chronic migraine in two multicenter, randomized, 3-month, double-blind, placebo-controlled studies (Study 1 and Study 2, respectively). In Study 1, a total of 875 patients (742 females, 133 males), ranging in age from 18 to 70 years, were randomized. A total of 791 patients completed the 3-month double-blind phase. The mean migraine frequency at baseline was approximately 9 migraine days per month, and was similar across treatment groups Both monthly and quarterly dosing regimens of AJOVY demonstrated statistically significant improvements for efficacy endpoints compared to placebo over the 3-month period, as summarized in Table 2. Table 2: Efficacy Endpoints in Study 1 Study 1Efficacy EndpointAJOVY 225 mgMonthly(N=287)AJOVY 675 mgQuarterly(N=288)Placebo (N=290) Monthly migraine days (MMD) Baseline migraine days8.99.29. 1 Change from baseline -3.7 -3.4 -2.2 Difference from placebo-1.5-1.2 p-value<0.001<0.001 ≥50% MMD responders % responders 47.7% 44.4% 27.9% Difference from placebo19.8%16.5% p-value <0.001<0.001

The efficacy of Ajovy (fremanezumab) for migraine prevention is supported by two clinical studies, Study 1 and Study 2.

• Key findings include:
  • Statistically significant improvements in efficacy endpoints compared to placebo over a 3-month period.
  • A mean change from baseline in monthly migraine days of -3.7 for the 225 mg monthly dose and -3.4 for the 675 mg quarterly dose.
  • A significant proportion of patients (47.7% and 44.4% for the monthly and quarterly doses, respectively) achieved at least a 50% reduction in monthly average number of migraine days.
  • The difference from placebo was statistically significant for both doses, with p-values < 0.001. 2

From the Research

Efficacy of Ajovy (Fremanezumab) for Migraine Prevention

• The efficacy of Ajovy (fremanezumab) for migraine prevention has been demonstrated in several studies 3, 4, 5, 6, 7.
• Fremanezumab has been shown to be effective in reducing the frequency of migraine days, headache days of at least moderate severity, and migraine- and headache-related disability compared with placebo 4, 5, 6, 7.
• In a phase 3 trial, fremanezumab quarterly and monthly dosing regimens resulted in a lower frequency of headache days compared with placebo, with a least-squares mean reduction of 4.3 and 4.6 days, respectively 4.
• The percentage of patients with a reduction of at least 50% in the average number of headache days per month was 38% in the fremanezumab-quarterly group, 41% in the fremanezumab-monthly group, and 18% in the placebo group 4.
• Fremanezumab has also been shown to be effective in patients with difficult-to-treat migraine, including those with comorbid depression, overuse of acute headache medications, and concomitant use of other migraine preventive medications 5, 6, 7.
• The long-term efficacy and safety of fremanezumab have been demonstrated in a 12-month long-term study, with sustained improvements in migraine frequency and related disability 5, 6.

Safety and Tolerability

• Fremanezumab has been shown to have a favorable tolerability profile, with no serious treatment-related adverse events reported in phase 3 clinical trials 3.
• The most common adverse events reported with fremanezumab were injection-site reactions, which were generally mild and transient 4, 7.
• Abnormalities of hepatic function occurred in a small percentage of patients receiving fremanezumab, but were not considered to be clinically significant 4.
• The safety and tolerability of fremanezumab have been demonstrated in patients with episodic and chronic migraine, including those with difficult-to-treat migraine 5, 6, 7.