General Information

Ajovy (fremanezumab-vfrm) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

Ajovy is specifically indicated for the preventive treatment of migraine in adults.

Ajovy is supplied as an injection for subcutaneous administration. Two subcutaneous dosing options of Ajovy are available to administer the recommended dosage: 225 mg monthly, or 675 mg every 3 months (quarterly), which is administered as three consecutive subcutaneous injections of 225 mg each. When switching dosage options, administer the first dose of the new regimen on the next scheduled date of administration. If a dose of Ajovy is missed, administer as soon as possible. Thereafter, Ajovy can be scheduled from the date of the last dose.

Clinical Results

FDA Approval

The FDA approval of Ajovy was based on two multicenter, randomized, 3-month, double-blind, placebo-controlled studies in adults with a history of episodic migraine (Study 1) or Chronic Migraine (Study 2).

Episodic Migraine:

The trial enrolled 875 adults with a history of episodic migraine (patients with <15 headache days per month). All patients were randomized (1:1:1) to receive subcutaneous injections of either Ajovy 675 mg every three months (quarterly), Ajovy 225 mg monthly, or placebo monthly, over a 3-month treatment period. Patients were allowed to use acute headache treatments during the study. The primary efficacy endpoint was the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period. Both monthly and quarterly dosing regimens of Ajovy demonstrated statistically significant improvements for efficacy endpoints compared to placebo over the 3-month period.

Chronic Migraine:

This trial enrolled 1,130 patients with <15 headache days per month. All patients were randomized (1:1:1) to receive subcutaneous injections of either Ajovy 675 mg starting dose followed by 225 mg monthly, 675 mg every 3 months (quarterly), or placebo monthly, over a 3-month treatment period. Patients were allowed to use acute headache treatments during the study. The subjects treated with Ajovy experienced statistically-significant reduction in the number of monthly headache days of at least moderate severity versus placebo (-2.5 days) during the 12 week period after first dose, for both monthly (-4.6 days p<0.0001) and quarterly (-4.3 days p<0.0001) dosing regimens. In addition, patients treated with Ajovy experienced significant improvement compared to placebo on all secondary endpoints for both monthly and quarterly dosing regimens, including: response rate, onset of efficacy, efficacy as monotherapy, and disability.