FDA Expands Ajovy Label to Include Pediatric Migraine Prevention
On Aug. 6, 2025, the US Food and Drug Administration (FDA) approved Teva Pharmaceuticals’ Ajovy® (fremanezumab-vfrm) injection for the preventive treatment of episodic migraine in children and adolescents aged six years to 17 years weighing 45kg or more. This marks the first and only calcitonin gene-related peptide receptor (CGRP) antagonist approved for pediatric episodic migraine prevention, expanding its initial 2018 approval for adult use. CGRP is a neuropeptide involved with vasodilation, inflammation and pain transmission associated with migraine attacks. About 7.1 million American children and adolescents suffer from migraines. A monthly, subcutaneous (SC) injection, Ajovy can be administered in-office or at home at a dose of 225mg for patients under 18 years. Here is the updated prescribing information.
Avtozma Biosimilar Achieves Approval for All Actemra Indications
The FDA approved Celltrion’s Avtozma® (tocilizumab-anoh) intravenous (IV) formulation for the treatment of cytokine release syndrome (CRS) on Aug. 7, 2025, now achieving full indication alignment with its reference product, Genentech’s Actemra® (tocilizumab) IV. The interleukin-6 (IL-6) receptor antagonist demonstrated comparable efficacy, safety and immunogenicity to Actemra in a phase III trial, supporting its approval in CRS in patients aged two years and older, including those undergoing chimeric antigen receptor (CAR) T-cell therapy. It is also indicated for treating active, moderate to severe cases of rheumatoid arthritis (RA) and giant cell arteritis in adults, and active cases of polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA) in patients who are as young as two years old and coronavirus disease (COVID-19). The recommended dose varies by indication and patient weight, with serious infection risks requiring close monitoring. Like Actemra, Avtozma will be available in vials for IV infusions and in single-dose prefilled syringes and autoinjector for SC use. Tofidence® (tocilizumab-bavi – Biogen), the first Actemra biosimilar that was approved in 2023, is available only as an IV form and Tyenne® (tocilizumab-aazg – Fresnius Kabi), the second approved in 2024, is available in both IV and SC form. Avtozma IV will be available starting Aug. 31, 2025, with SC formulation launch details remaining unknown. The updated prescribing information is here.
MedWatch Update
Ixchiq Hold Lifted with Added Label Restrictions On Aug. 6, 2025, the FDA both lifted a recommendation on pausing use of Ixchiq® (live-attenuated chikungunya virus vaccine – Valneva) in older adults and added new warnings to its labeling. The FDA had requested a temporary pause on Ixchiq for individuals aged 60 years and older, prompted by post-marketing reports of serious adverse events, including two deaths. After an updated benefit-risk assessment, the pause is lifted along with updated prescribing information. Warnings and precautions have been broadened to highlight the increased risk of serious adverse events, particularly in adults aged 65 years and older with underlying chronic conditions. The label also emphasizes that vaccination is not advisable for most US travelers, given the low domestic risk of exposure. The indication for Ixchiq has been revised to specify use in adults aged 18 years and older who are at high risk of chikungunya virus exposure, rather than broadly referencing increased exposure risk. Ixchiq contains a live, weakened version of the chikungunya virus and in rare cases, the side effects were consistent with complications of the virus. The safety communication may be found here.