Amgen announced new data in patients with high unmet need, providing further evidence of the efficacy of Aimovig (erenumab) for migraine prevention. Aimovig is the first and only investigational biologic product specifically designed to prevent migraine by blocking the calcitonin gene-related peptide (CGRP) receptor, which is associated in migraine activation. The data include a pre-planned sub-analysis from the pivotal Phase 2 chronic migraine study, demonstrating that Aimovig reduced the number of monthly migraine days (MMDs) in patients who have failed previous preventive therapies. Additionally, results from a dedicated study in patients with stable angina adds further support to the safety profile of Aimovig. These results will be presented at the 18th Congress of the International Headache Society in Vancouver, Canada.
"Data from our robust clinical development program continue to show that Aimovig has demonstrated efficacy in a broad range of patients, including hard-to-treat chronic migraine sufferers who have previously tried and failed other preventive therapies," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Separately, new results from a treadmill safety study showed no adverse cardiovascular effect compared to placebo in patients with coronary artery disease and stable angina, which complements our extensive safety database and ongoing long-term extension studies of Aimovig for migraine prevention."
Studies have shown that up to 80 percent of people with migraine discontinue preventive treatment within one year. In a pre-specified sub-analysis from the Phase 2 study, Aimovig showed benefits for people with chronic migraine who have previously tried and failed preventive treatments. At the end of the 12-week study, patients who had failed two or more prior preventive treatments experienced a reduction of 7.0 days and 5.4 days in the Aimovig 140 mg and 70 mg, respectively, compared to placebo reduction of 2.7 days (p<0.001). Furthermore, in the Aimovig treated arms, the odds of cutting migraine days in at least half was three-to-four fold higher than in the placebo arm (140 mg: 41.3 percent, 70 mg: 35.6 percent, placebo: 14.2 percent (p<0.001 for both doses versus placebo).
The safety profile of Aimovig was similar to placebo across both treatment arms in the Phase 2 study. No adverse event was reported in greater than five percent of patients treated with Aimovig; the most common adverse events were injection site pain, upper respiratory tract infection and nausea.
These results are consistent with the known safety profile of Aimovig, as seen across the broad clinical program involving more than 2,600 migraine patients.
Regulatory submissions for Aimovig have been filed in the United States (U.S.) and Europe. The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 17, 2018. If approved, Novartis and Amgen will co-commercialize Aimovig in the U.S. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in rest of world.
Aimovig is the only investigational biologic product specifically designed to prevent migraine by blocking the CGRP receptor, which is associated with migraine activation. Aimovig has been studied in several large global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention. More than 2,600 patients have been exposed to Aimovig across the four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extension.