Amgen, Novartis Announce Positive Long-Term Efficacy and Safety Data of Erenumab for Migraine

Amgen and Novartis have announced positive long-term efficacy, safety, and tolerability data of erenumab-aooe (Aimovig) in patients with chronic and episodic migraine.

According to the pharmaceutical companies, the calcitonin gene-related peptide (CGRP) inhibitor has demonstrated efficacy and safety in a 1-year study in chronic migraine and reinforced safety and tolerability in a 3-year interim analysis from an ongoing 5-year study in episodic migraine.

“On the heels of the recent FDA approval of Aimovig for the preventive treatment of migraine in adults, the results of these open-label extension studies are encouraging as they contribute to a growing and extensive body of evidence that support the use of Aimovig across the spectrum of migraine, said Sean E. Harper, MD, executive vice president, research and development, Amgen, in a statement.

Erenumab became the first FDA-approved CGRP inhibitor for the prevention of migraine in May, following positive results from the LIBERTY trial, which assessed the treatment in patients with episodic migraine who had previously failed on 2 to 4 other treatments.

In the current 1-year open-label study in 451 patients with chronic migraine, patients taking 140 mg and 70 mg of erenumab experienced reductions of average monthly migraine days of 10.5 days and 8.5 days, respectively, compared to a baseline of 18.1 days. Sixty-seven percent of patients on 140 mg and 53% of patients on 70 mg achieved a 50% reduction or more in monthly migraine days; 42% of patients on 140 mg and 27% of patients on 70 mg achieved a 75% reduction or more; and 13% of patients on 140 mg and 6% of patients on 70 mg achieved a 100% reduction.

Safety results were consistent with those in previous studies, and efficacy data showed sustained benefits up to 1 year.

“These data showing sustained efficacy and consistent safety and tolerability of Aimovig over an extended period of time are important for migraine patients and their clinicians to know,” said Stewart J Tepper, MD, professor of neurology, Geisel School of Medicine, Dartmouth Medical School.

In the 5-year open-label study in episodic migraine, 383 patients entered the open-label extension phase of the study after completing the 12-week randomized, placebo-controlled phase. During the extension, patients initially received 70 mg of erenumab monthly, until a protocol amendment increase the dosage to 140 mg monthly.

Results of the 3-year analysis of the 235 patients who remained in the study at data cutoff found that erenumab had a safety profile consistent with the spectrum and rate of adverse events demonstrated in shorter-term placebo-controlled trials, no new adverse events, and no new causally-related serious adverse events.