Ajovy Injection Approved for Migraine Prevention in Adults
本帖最后由 xiuxuankim 于 2018-10-6 00:42 编辑Teva announced that the Food and Drug Administration (FDA) has approved Ajovy (fremanezumab-vfrm) subcutaneous injection for the preventive treatment of migraine in adults.
Ajovy is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks it binding to the receptor. This is the first anti-CGRP drug for migraine prevention that is available as quarterly and monthly dosing regimens. Ajovy may be given as an in-office treatment by a healthcare professional or at home by the patient or a caregiver.
Two Phase 3, placebo-controlled trials (Study 1 and Study 2) evaluated Ajovy monotherapy and as combination therapy with oral preventive drugs in patients with disabling migraine. Study 1 (N=875) randomized adults with a history of episodic migraine to receive subcutaneous Ajovy 675mg every 3 months, Ajovy 225mg monthly, or placebo monthly, for 3 months. 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 options of Ajovy showed statistically significant improvements for efficacy endpoints vs placebo over the 3-month period. There was a reduction of3.7 days and 3.4 days of monthly migraine days (MMD) from baseline in the Ajovy 225mg monthly and Ajovy 675mg quarterly dosing groups, respectively, compared with 2.2 days in the placebo group.
Study 2 (N=1130) randomized adults with a history of chronic migraine to receive Ajovy 675mg followed by 225mgmonthly, 675mg every 3 months, or placebo monthly, for 3 months. The primary efficacy endpoint was the mean change from baseline in the monthly average number of headache days of at least moderate severity during the 3-month treatment period. Both monthly and quarterly dosing options of Ajovy showed statistically significant improvements for efficacy endpoints vs placebo over the 3-month period. There was a reduction of -4.6 days and -4.3 days in the monthly average number of headache days of at least moderate severity in the Ajovy 225mg monthly and Ajovy 675mg quarterly dosing groups, respectively, compared with -2.5 days in the placebo group.
Injection site reactions were the most common adverse reactions associated with Ajovy.
Ajovy will be supplied as a 225mg/1.5mL strength, preservative-free, single-dose prefilled syringe. It is anticipated to launch in approximately 2 weeks.
For more information call (888) 483-8279 or visit Ajovy.com.
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