The first-in-class injectable, Aimovig, gains approval.
Migraine sufferers experience intense, throbbing headache pain often accompanied by nausea and/or vomiting and sensitivity to light and sound. About one-third of people that experience migraines, which can be triggered by stress, hormonal changes, bright or flashing lights, lack of food or sleep and diet, can predict when they will occur because they experience transient sensory or visual disturbances.
The US Food and Drug Administration has approved the first preventive migraine treatment for adults in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide (cGRP), a molecule that is involved in migraine attacks. Aimovig (erenumab-aooe), a biologic, is self-administered via injection once per month.
“Aimovig provides patients with a novel option for reducing the number of days with migraines,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We need new treatments for this painful and often debilitating condition.”
Approval for Aimovig was granted to Amgen. The company is co-marketing the drug with Novartis according to a partnership initially established in 2015 and expanded in April. Amgen will book all US sales and pay Royalties to Novartis, while the latter will book sales outside the US and pay royalties to Amgen. Amgen has exclusive rights in Japan, and Novartis has exclusive rights in Canada.
The cGRP class of drugs is attracting a lot of interest because they are the first drugs to be specifically developed for the prevention of migraines. Older drugs used for this purpose were initially developed to treat other diseases and generally fall short. There are a number of other companies developing competitive products, including Eli Lilly, Teva and Allergan. Eli Lilly is expected to reach the market first. Allergan is developing an oral drug in more initial stages.
Questions have been raised, however, about the high cost of the new drug. In advance of the approval, payers had warned that the annual price should be lower than $8,000 to $10,000. Amgen has responded with an initial price of $6900 per year.