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Clinical trials investigated the long-acting, anti-CGRP injection for the preventive treatment of migraine

AJOVY was evaluated in three phase 3, 12-week, randomized, double-blind, placebo controlled, parallel-group trials, and a long-term extension study1,2

HALO TRIAL DESIGNSCHRONIC MIGRAINE (CM) & EPISODIC MIGRAINE (EM)

  • 1000+

    patients received AJOVY as a stand-alone preventive treatment1

    280+

    patients continued to receive their oral preventive treatment1

  • Nearly 600

    patients had discontinued prior preventive treatment2

    18%

    of women of childbearing age also took concomitant hormonal contraceptives2

  • There are no adequate data on the developmental risk associated with the use of AJOVY in pregnant women. This should be taken into consideration for women who are pregnant or plan to become pregnant while using AJOVY.1

AJOVY quarterly treatment arm2

Single dose of 675 mg at week 0 (three injections of 225 mg per 1.5 mL), followed at weeks 4 and 8 by placebo (one 1.5 mL injection at each visit)

AJOVY monthly treatment arm2

CM: 675 mg dose at week 0 (three injections of 225 mg per 1.5 mL) and 225 mg at weeks 4 and 8 (one injection of 225 mg per 1.5 mL at each visit)

EM: 225 mg dose at weeks 0 (one injection of 225 mg per 1.5 mL and two 1.5 mL injections of placebo), and 225 mg at weeks 4 and 8 (one injection of 225 mg per 1.5 mL at each visit

Placebo treatment arm2

Three 1.5 mL injections at week 0 and one 1.5 mL injection at weeks 4 and 8

CM: defined as 15 headache days per month.6

EM: defined as <15 headache days per month.

LONG-TERM EXTENSION STUDYCHRONIC MIGRAINE (CM) & EPISODIC MIGRAINE (EM)

  • AJOVY was evaluated in a 12-month, multicenter, randomized, double-blind, parallel-group study evaluating monthly or quarterly dosing.

  • As the primary purpose of the study was the collection of long-term safety data for patients treated with AJOVY, the study was not placebo controlled. Patients and investigators were both blinded to the dosing regimen (quarterly vs monthly) to allow for comparisons between the two dosing options.

    The study included 1890 patients with CM (1,110) and EM (780).2

AJOVY quarterly treatment arm2

Single dose of 675 mg at month 0 (three injections of 225 mg per 1.5 mL), followed by month 3, 6, 9, and 12, and placebo (one 1.5 mL injection) at months 1, 2, 4, 5, 7, 8, 10, and 11

AJOVY monthly treatment arm2

CM (HALO placebo & new patients): 675 mg dose at month 0 (three injections of 225 mg per 1.5 mL), followed by 225 mg at months 1–12

CM (HALO patients): 225 mg dose at months 0–12 (one injection of 225 mg per 1.5 mL and two 1.5 mL injections of placebo)

EM (HALO & new patients): 225 mg dose at months 0–12 (one injection of 225 mg per 1.5 mL and two 1.5 mL injections of placebo)

CM: defined as 15 headache days per month.2

EM: defined as <15 headache days per month.

FOCUS TRIAL DESIGNCHRONIC MIGRAINE (CM) & EPISODIC MIGRAINE (EM)

  • AJOVY was evaluated in a phase 3b, multicenter, randomized, double-blind, parallel-group, placebo-controlled study evaluating efficacy and safety of quarterly and monthly treatment with AJOVY, compared to placebo in patients with chronic or episodic migraine who had experienced an inadequate response* to 2–4 classes of prior preventive treatments.5

  • The study randomized 838 patients with chronic and episodic migraine2

    *Inadequate response to a prior medication was defined as: (1) no clinically meaningful improvement after at least 3 months (2) patient could not tolerate the drug (3) drug was contraindicated for patient or (4) drug was not suitable for the patient.5

AJOVY quarterly treatment arm2

Single dose of 675 mg at week 0 (three injections of 225 mg per 1.5 mL), followed at weeks 4 and 8 by placebo (one 1.5 mL injection at each visit)

AJOVY monthly treatment arm2

CM: 675 mg dose at week 0 (three injections of 225 mg per 1.5 mL) and 225 mg at weeks 4 and 8 (one injection of 225 mg per 1.5 mL at each visit)

EM: 225 mg dose at week 0 (one injection of 225 mg per 1.5 mL and two 1.5 mL injections of placebo), and 225 mg at weeks 4 and 8 (one injection of 225 mg per 1.5 mL at each visit)

Placebo treatment arm2

Three 1.5 mL injections at week 0 and 1.5 mL injection at weeks 4 and 8

CM: defined as headache occuring on 15 days.2

EM: defined as headache occurring on ≥6 days but <15 days.

Suggestions to explore next

Continue to AJOVY Efficacy page

AJOVY helped significantly reduce monthly migraine days vs placebo1

See the clinical trial results for AJOVY
Continue to AJOVY side effects pageContinue to AJOVY side effects page

Safety profile in clinical trials for AJOVY1

Side effects for ajovy
Continue to AJOVY Dosing page

Only 4 injection days per year with quarterly dosing1

dosing for AJOVY