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Teva's Ajovy injection secures EU approval for the prevention of migraine

Published on 02/04/19 at 10:54am

Teva has announced that its calcitonin gene-related peptide (CGRP) inhibitor Ajovy (fremanezumab) has been awarded marketing authorisation by the European Commission in 225 mg pre-filled syringe form for the prophylaxis of migraine in adult patients who have at least four migraine days per month.

The approval means that Ajovy becomes the first and only CGRP inhibitor authorised for use in both the European Union and the US which is available in quarterly and monthly dosing options as a preventative treatment for migraine.

Data from two Phase 2 trials supported the application, demonstrating that Ajovy led to a “significantly greater reduction in migraine days” compared to placebo among patients with disabling migraine.

“Migraine is not just a headache, it is an unpredictable neurological disease which can frequently go undiagnosed and undertreated,” commented Elena Ruiz de la Torre, Executive Director, European Migraine & Headache Alliance. “After decades of migraine patients feeling left behind, we are delighted to see the progression of preventive treatments which offer patients new hope in managing their condition. The availability of a new treatment, which is specifically designed for the prevention of migraine, is another positive step forward for the migraine community and we welcome the fact that Europe’s more than 50 million patients will now have greater choice over their treatment options and more days uninterrupted by migraine.”

Richard Daniell, Executive Vice President, European Commercial at Teva, also commented: “Migraine can have a significant impact on the day-to-day life of patients with some experiencing 15 headache days per month. It is our hope that Ajovy will provide patients and European healthcare professionals with a preventive treatment which offers patients more migraine free days as well as greater flexibility in managing this unpredictable disease. The approval of fremanezumab is also an important step in our focus on biopharmaceuticals, the next generation of innovative medicines, coupled with our ongoing commitment to developing treatments for disorders of the central nervous system (CNS).”

Matt Fellows

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