FDA approves preventative treatment for migraines


Aimovig (erenumab) has been cleared by the United States regulator as a once-monthly, self-injected preventive treatment for migraines based on data from three clinical trials which showed the drug was able to reduce the number of migraine days in a month compared to placebo. Aimovig can help in the prevention of a migraine by interviewing with the calcitonin gene-related peptide that is actively involved in the process that can eliminate a migraine that takes place because of blood vessel dilation in the brain.

"Cluster headache can be hard to evaluate in clinical studies, which has contributed to few available treatment options for clusterheadache, often considered the most severe pain one can experience", noted Christi Shaw, president of Lilly Bio-Medicines, in the release. The drug is available for self-administering once a month using Amgen Inc.'s (AMGN) SureClick auto-injector. The condition is three times more common among women than men.

Companies including Teva Pharmaceutical Industries, Eli Lilly & Co, and Alder Biopharmaceuticals Inc are developing similar treatments.

The second three-month trial included 577 episodic migraine patients, where patients experienced on average one fewer migraine day per month than those on placebo. The multicenter, randomized, double-blind, placebo-controlled, parallel group trial (n = 875) met its primary endpoint demonstrating that fremanezumab significantly reduced monthly migraine days for both dosing regimens.

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Novartis and Amgen plan to co-commercialise Aimovig in the U.S., while Amgen has exclusive commercialisation rights in Japan and Novartis in rest of world. Compared to a placebo, Aimovig also resulted in a significant reduction in the use of acute migraine medications. Atogepant, the company's preventative treatment, is now in phase 2 clinical trials.

The new treatment, a monthly injection, is called Aimovig. These effects on monthly migraine days have been shown to be sustained for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days per month).

They can be debilitating, and are one of the most disabling illness in the world, the Migraine Research Foundation reports. "Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success".

Side-effects of erenumab, as reported in clinical trials, were very low.