Teva Pharmaceuticals Reports the US FDA’s sBLA Acceptance of Ajovy (Fremanezumab) for Pediatric Episodic Migraine Prevention
Shots:
- The US FDA has accepted sBLA of Ajovy to prevent episodic migraine in children & adolescents (6-17yrs.; ≥45Kg)
- Submission was based on P-III (SPACE) trial assessing Ajovy (SC) vs PBO for 12wks. to treat episodic migraine in 237 pediatric pts, which showed improvements in reducing monthly migraine & headache days
- Ajovy (CGRP antagonist) is available as a 225 mg/1.5 mL single-dose pre-filled syringe or pen, with 2 dosing options: 225mg (QM as 1 injection) or 675mg (Q3M as 3 injections) as SC formulation
Ref: Globenewswire | Image: Teva
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