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Novartis and Amgen Announce FDA Approval of Aimovig™

Wednesday, May 23, 2018   (0 Comments)
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Last week, Novartis and Amgen announced the FDA approved Aimovig™ (erenumab) for the preventive treatment of migraine in adults. The FDA granted approval to Amgen; however, Amgen and Novartis have entered into a global collaboration to develop and commercialize treatments in the field of migraine. As part of this agreement, the two companies will co-commercialize Aimovig™ in the U.S. Amgen retains exclusive commercialization rights in Japan, and Novartis has exclusive commercialization rights in Europe, Canada, and the rest of the world.

Aimovig™ is a monoclonal antibody that targets the calcitonin gene-related peptide receptor. According to the FDA,“Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.” Aimovig™ is self-administered via a subcutaneous injection at a dose of 70 mg once monthly, although some patients may be prescribed a dosage of 140 mg once monthly.

Novartis and Amgen expect that Aimovig™ will be available as soon as this week. The two companies have also announced that Aimovig™ is expected to cost $575 per month, or $6,900 annually.

According to some experts, the global market for migraine drug sales is around $4 billion per year and is expected to grow to $8.7 billion by 2026. Thus, it is not surprising that although Amgen is the first to obtain approval for a product that interferes with CGRP signaling, it is not the only company pursing this avenue. Indeed, Eli Lilly and Company, Teva, and Alder Biopharmaceuticals all have similar products that are either currently under review by the FDA or are expected to be shortly.


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