The FDA has approved a new drug called Ajovy (fremanezumab) for preventing migraines. It is for adults and for children ages 6 to 17 who weigh at least 45 kg (about 99 pounds). Ajovy is a shot given under the skin. Adults can choose a monthly or quarterly dose. Children get a monthly dose. In studies, people taking Ajovy had fewer migraine days each month compared to those on a placebo. This approval offers a new choice for people who need to prevent migraines. It is not a treatment for a migraine that has already started. Ajovy is not approved for children who weigh less than 45 kg because there is no right dose size for them. If you or your child gets migraines, talk to your doctor. They can help decide if Ajovy might be a good option for prevention.
FDA approved Ajovy (fremanezumab) for Preventive Migraine Treatment in Adults and Pediatric PatientsFDA approved Ajovy to prevent migraines in adults and children.
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The FDA has approved Ajovy (fremanezumab), a calcitonin gene-related peptide antagonist, for the preventive treatment of migraine in adults and for episodic migraine in pediatric patients aged 6 to 17 years who weigh 45 kg or more. The approval provides a new option for migraine prevention, including a quarterly dosing regimen for adults. In clinical trials, Ajovy demonstrated statistically significant reductions in monthly migraine days compared with placebo over a 3-month period. The drug is administered subcutaneously and offers flexibility with monthly or quarterly dosing for adults. For pediatric patients, the recommended dose is 225 mg monthly. Ajovy is not approved for children weighing less than 45 kg due to lack of an appropriate strength presentation.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Fremanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and blocks its binding to the receptor.
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.
For subcutaneous use only. Adults: 225 mg monthly or 675 mg every 3 months (quarterly, as three consecutive injections of 225 mg each). Pediatric patients (6-17 years, ≥45 kg): 225 mg monthly. Administer in abdomen, thigh, or upper arm. Allow to sit at room temperature for 30 minutes before use. Do not use if solution is cloudy, discolored, or contains particles.
In Study 1 (NCT02629861), a 3-month double-blind placebo-controlled trial in adults with episodic migraine (mean 9 migraine days/month), Ajovy 225 mg monthly and 675 mg quarterly both significantly reduced monthly migraine days vs placebo (change from baseline: -3.7, -3.4, and -2.2, respectively; p<0.001). Secondary endpoints including ≥50% reduction in migraine days and reduction in acute headache medication use also favored Ajovy.
Not reported in label.
Ajovy provides a preventive treatment option for migraine in adults and pediatric patients. Its quarterly dosing option may offer convenience for some patients. The drug is not approved in pediatric patients weighing less than 45 kg.
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