FDA Approves Prefilled Autoinjector Device for Ajovy

The Food and Drug Administration (FDA) has approved an autoinjector device for Ajovy (fremanezumab-vfrm; Teva) injection for the preventive treatment of migraine in adults. 

Fremanezumab is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks it from binding to the receptor. The new single-dose prefilled autoinjector includes a viewing window, needle shield and audible clicks to guide patients and caregivers through successful administration into the upper arm, thigh or abdomen. Administration of 1 dose of Ajovy via the prefilled autoinjector takes approximately 30 seconds.

“Ajovy is the only FDA-approved anti-CGRP that offers the flexibility of quarterly (675mg) or monthly (225mg) dosing options, and we are pleased that patients and their healthcare providers will be able to decide if an autoinjector is the right administration option for their needs,” said Brendan O’Grady, executive VP, North America Commercial, Teva.

Ajovy is currently available as a 225mg/1.5mL prefilled syringe. The new autoinjector device is expected to be available in the coming months as a 225mg/1.5mL single-dose prefilled autoinjector in a pack of one. 

For more information visit tevapharm.com.