FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Europe Approves Teva’s Ajovy for Migraine

April 11, 2019

The European Commission has approved Teva’s Ajovy (fremanezumab) to help prevent migraines. Ajovy is a monoclonal antibody that can be injected either monthly or quarterly.

European regulators approved the treatment after two Phase III trials showed that patients in the Ajovy group suffered at least half as many migraine days as patients in the placebo group.

Hypersensitivity reactions, including rash, itching, drug hypersensitivity and hives, were reported in the clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment.

The FDA approved Ajovy in September 2018.

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