PRIMARY ENDPOINT1
Pediatric patients randomized to monthly dosing had a mean baseline of 7.8 migraine days per month and experienced, on average:
2.5
FEWER MIGRAINE DAYS
at month 3 vs 1.4
with placebo (P<0.021)
AJOVY is indicated for the preventive treatment of migraine in adults, and the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more.
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IN PEDIATRIC PATIENTS WITH EPISODIC MIGRAINE 6–17 YEARS OF AGE, WHO WEIGH ≥45 KG,
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Pediatric patients randomized to monthly dosing had a mean baseline of 7.8 migraine days per month and experienced, on average:
2.5
FEWER MIGRAINE DAYS
at month 3 vs 1.4
with placebo (P<0.021)
≥50%
REDUCTION
in monthly number of migraine days with
monthly dosing
47.2% on AJOVY vs 27%
on placebo (P<0.002)
The most common adverse reactions for AJOVY observed in the pediatric EM trial were injection-site reactions,† similar to the overall safety profile observed in long-term adult clinical studies1
†Injection-site reactions include multiple related adverse event terms, such as injection-site erythema, swelling, and pain.
ONCE-MONTHLY DOSE
for pediatric patients is the same as the monthly dose for adults
MONTHLY
AJOVY 225 mg/1.5 mL autoinjector
Sig: 225 mg subcutaneous (1 autoinjector)
every month
Dis: 1.5 mL
Refills: 11
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CGRP: calcitonin gene-related peptide; EM: episodic migraine.
*Pediatric EM trial design: AJOVY was evaluated in a phase 3 multicenter, randomized, double-blind, placebocontrolled, parallel-group study comparing the efficacy, safety, and tolerability of subcutaneous administration of AJOVY (n=123) vs placebo (n=111§) over a 12-week period for the preventive treatment of episodic migraine (<15 headache days per month) in 235 pediatric patients aged 6 to 17 years. The primary efficacy endpoint was the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period. Secondary endpoints included the proportion of patients reaching ≥50% reduction in monthly average number of migraine days during the 3-month treatment period, the mean change from baseline in the monthly average number of days of use of any acute headache medication during the 3-month treatment period, and the mean change from baseline in the monthly average number of headache days of at least moderate severity during the 3-month treatment period.
‡Out-of-pocket costs may vary based on insurance coverage. Exclusions and limitations apply. Please note, this offer is not available for patients eligible for Medicare, Medicaid, or any other public payer coverage. See full Terms and Conditions for eligibility and restrictions.
§One patient in the placebo group was excluded from the analysis due to not having at least 10 days of postbaseline efficacy data.
References: 1. AJOVY® (fremanezumab-vfrm) injection Current Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc. 2. Aimovig® (erenumab-aooe) injection. Prescribing Information. Thousand Oaks, CA: Amgen Inc. 3. Emgality® (galcanezumab-gnlm) injection. Prescribing Information. Indianapolis, IN. Lilly USA, LLC. 4. Data on file. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.