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Teva's Ajovy reduces headache days in previously treated migraine patients

Teva Pharmaceutical Industries Ltd.'s medicine Ajovy was effective in a late-stage study in reducing headache days for migraine patients who had received prior therapy.

The Israeli pharmaceutical giant evaluated Ajovy, or fremanezumab, against placebo in 838 patients with chronic and episodic migraine in a phase 3b trial called Focus, according to a Dec. 17 press release. The trial specifically studied patients who had not benefited from two to four types of prior therapies.

A migraine is a disabling neurological disease characterized by severe head pain, nausea and vomiting. Patients with episodic migraines have between zero and 14 headache days per month, while chronic migraines are 15 or more headache days per month.

After 12 weeks of treatment, Ajovy met the trial's main goal of significantly reducing the monthly average number of migraine days versus placebo under both monthly and quarterly dosing regimens of the medicine. The company said patients treated with the medicine experienced significant improvement compared to placebo on all secondary goals for both dosing regimens and no safety signals were detected in the study.

Teva plans to submit the full results of the trial for medical meetings in 2019.

Ajovy belongs to a group of medicines known as calcitonin gene-related peptide inhibitors. The group includes Eli Lilly and Co.'s Emgality and Amgen Inc. and Novartis AG's Aimovig, both of which were included for 2019 coverage by Express Scripts Holding Co. while Ajovy was not. Ajovy was approved by the U.S. Food and Drug Administration in September as a preventive treatment of migraines in adults.