Teva’s AJOVY Secures Landmark FDA Approval
Teva Pharmaceuticals has achieved a major milestone in migraine care with the US Food and Drug Administration (FDA) granting approval for AJOVY® (fremanezumab-vfrm) as a preventive treatment for episodic migraine in children and adolescents aged 6–17 who weigh at least 45 kilograms.
This landmark decision makes AJOVY the first and only calcitonin gene-related peptide (CGRP) antagonist authorised for paediatric episodic migraine prevention as well as adult migraine treatment.
Previously approved in 2018 for adults, AJOVY’s new indication reflects Teva’s ongoing commitment to advancing neuroscience therapies and widening access to innovative treatments.
A Long-Awaited Option for Younger Patients
Migraine affects around one in ten children and adolescents in the United States, often resulting in missed school days, disrupted social activities, and significant emotional challenges.
Despite its prevalence, paediatric migraine has long been underrecognised and undertreated, leaving families with limited preventive options.
AJOVY’s once-monthly injection offers flexibility to families, as it can be administered either in a clinic or at home. The availability of a targeted preventive treatment is expected to reduce the frequency of migraine attacks, helping children and adolescents better manage the condition and maintain their day-to-day activities.
Industry and Clinical Perspectives
Teva’s Executive Vice President welcomed the FDA approval, highlighting that it addresses a critical gap in migraine care.
With this FDA approval, AJOVY now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition.
Echoing this sentiment, a Paediatric Neurologist at the DENT Neurologic Institute emphasised the importance of having a dedicated treatment for this age group.
They commented that having an FDA-approved treatment like AJOVY offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients.
The Impact of Migraine in Childhood
Migraine is a disabling neurological disorder, characterised by pain, nausea, and sensitivity to light and sound. In children and adolescents, these symptoms can extend beyond physical discomfort, disrupting learning, impacting school performance, and affecting social and emotional well-being.
Therefore, the approval of AJOVY brings hope of a more stable and supportive environment for families managing this complex condition.
A Step Forward in Migraine Care
By extending AJOVY’s use to younger patients, Teva Pharmaceuticals is setting a precedent in the field of migraine treatment. This expansion not only strengthens the company’s neuroscience portfolio but also signals progress towards bridging treatment gaps across different age groups.
For families and clinicians alike, the FDA’s approval of AJOVY represents a meaningful step forward – offering children and adolescents with episodic migraine a reliable, science-backed preventive option for the first time.
News Credits: FDA approves AJOVY for paediatric migraine prevention
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