FDA Approves Erenumab, First CGRP Inhibitor for Prevention of Migraine

The FDA has approved Amgen and Novartis’ erenumab-aooe, marking the first approved calcitonin gene-related peptide (CGRP) inhibitor for the prevention of migraine in adults. The treatment will cost 30% less than expected.

The FDA has approved Amgen and Novartis’ erenumab-aooe (Aimovig), marking the first approved calcitonin gene-related peptide (CGRP) inhibitor for the prevention of migraine in adults.

The once-monthly self-injected treatment works by blocking the CGRP receptor, which is believed to play a crucial role in migraine. The treatment is expected to be available to patients within a week.

Both the FDA and Amgen and Novartis underscored the importance of having a new option for the treatment of migraine, which has everyday and long-lasting impacts on migraineurs’ lives. In addition to the comorbidities associated with migraine, the condition often leads to lost productivity and work days. A report from the United Kingdom found that migraine is responsible for 86 million lost work days and costs £8.8 billion annually in lost productivity.

“Migraine is a serious neurological disease that has dramatic effects on patients’ lives. 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,” said Sean E. Harper, MD, executive vice president of research and development, Amgen, in a statement. “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.”

The approval comes a month after Amgen and Novartis announced positive results from the LIBERTY trial, which assessed the treatment in patients with episodic migraine who had previously failed on 2 to 4 treatments.

The study included 246 patients randomized 1:1 to receive monthly injections of either 140 mg of erenumab or placebo for 12 weeks. Results showed that those taking erenumab had nearly 3-fold higher odds of having their migraine days reduced by at least 50% (30.3% versus 13.7%). Safety and tolerability were comparable to placebo, and no patients in the erenumab cohort discontinued due to adverse events.

The list price for the treatment is $575 for once-monthly 70 mg or 140 mg single-use autoinjectors, or $6900 annually. The price comes cheaper than expected, as many analysts predicted the treatment to cost around $10,000 a year, reported STAT news.

In April, the Institute for Clinical and Economic Review released a draft evidence report assessing the cost-effectiveness of the treatment and found that, with a placeholder price of $8500 a year, erenumab fell under the cost effectiveness ratio threshold.