FDA Approves Amgen and Novartis Migraine Drug Aimovig, Expected to Be Ready for Patients in 1 Week

FDA Approval

Amgen and Novartis scored a big win in the migraine market late Thursday when the U.S. Food and Drug Administration (FDA) approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The drug will launch with a list price of $6,900 per year and is expected to be available within a week.

The migraine medication was approved based off of stunning Phase III data that showed Aimovig reduced monthly migraine attacks in half. The medication developed by the two powerhouse companies is the only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R). CGRP is believed to play a significant role in migraine and cluster headaches. A dedicated Phase IIIb study in difficult-to-treat populations, patients who have episodic migraines but have failed two to four prior treatments, showed that patients taking Aimovig had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo.

Amgen and Novartis are the first to the finish line with the CGRP treatments. Other companies with significant investments in migraine headache research like Allergan (ubrogepant), Teva (fremanezumab), Eli Lilly (galcanezumab) and Alder BioPharmaceuticals (Eptinezumab) are also focused on the pathway as a treatment for the devastating headaches.

Migraines impact about 12 percent of the population in the United States, including children. The pain and other symptoms associated with migraines can cause sufferers to completely stop what they are doing and prevent them from working or functioning in a normal capacity for more than a day. Episodic migraine sufferers typically deal with four to 14 migraine days per month. Patients who used Aimovig in trials were able to sustain the migraine reductions sustained for up to 15 months in an ongoing open-label extension study in episodic migraine.

Sean Harper, head of Research and Development at Amgen, said migraine headaches are a serious neurological disease that have dramatic effects on the lives of people.

“Migraine patients experience excruciating headache pain, often accompanied by other symptoms such as nausea and vomiting, and many live in constant dread of the next attack. The FDA approval of Aimovig represents a long-awaited and important therapeutic development for patients and their physicians who are in need of additional treatment options for the prevention of migraine,” Harper said in a statement.

Unlike Allergan’s Botox injection, one of the more common migraine treatments, Aimovig is self-administered once per month. The medication is injected via Amgen’s SureClick autoinjector. The company said it does not require a loading dose. A single-use prefilled dose of Aimovig will be available in 70 or 140 mg doses and will average $575 per injection. Amgen predicts some patients will only pay $5 in out of pocket costs depending on insurance and other programs. With the migraine medication ready to launch within a week, Amgen and Novartis have also established a patient support program called Aimovig Ally. The support program has been created to help patients navigate insurance coverage and identify potential access resources for those who are uninsured or underinsured, Amgen said.

That pricing will certainly alleviate the concerns of major prescription provider Express Scripts, which has been pressuring Amgen and other companies developing migraine medications to keep consumer prices low.

European migraine sufferers will have to wait a few more months for Aimovig. The medication is currently under review by the European Medicines Agency. A decision is expected in coming months, Amgen said.

Subscription JPEG

Back to news