Teva has announced that fremanezumab, its new treatment for preventing migraines, has been accepted for regulatory review by the European Medicines Agency.
The EU regulator has accepted the marketing authorisation application for the new anti-calcitonin gene-related peptide antibody, which is intended for the prevention of episodic and chronic migraine in adults.
“Teva's new migraine therapy fremanezumab has been accepted for European regulatory review.“
This quarterly or monthly injection-based therapy can be administered by a healthcare professional or self-administered by the patient, and has been clinically proven to deliver strong safety and efficacy.
In the HALO clinical trial programme, which enrolled more than 2,000 patients with episodic and chronic migraine, both dosing regimens of fremanezumab achieved statistically significant results across all trial endpoints.
This comes after the US Food and Drug Administration recently accepted a biologics licence application for this promising therapy.
Dr Ernesto Aycardi, vice-president and head of clinical trial execution, data sciences and biometrics and clinical pharmacology at Teva, said: "These two significant regulatory milestones in the migraine indication, combined with our clinical development programmes for fremanezumab in cluster headache and post-traumatic headache, highlight Teva's commitment to patients worldwide with these debilitating conditions."
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