Novartis/Amgen migraine drug shows promise

Novartis and Amgen’s AMG 334 (erenumab) significantly reduced monthly migraine days compared with placebo, according to phase 2 trial results.

The drug is from a neuroscience collaboration between Novartis and Amgen, where the companies are looking to develop and market treatments in Alzheimer’s disease and migraine.

EP Vantage expects Erenumab to bring in sales of almost half a billion in 2022 if approved, although a rival migraine drug being developed by Teva could bring in sales north of a billion by that time.

Significantly more patients receiving monthly subcutaneous AMG 334 70mg or 140mg experienced a 50% or more reduction in the number of monthly migraine days compared with placebo.

The study included 667 patients who had a mean baseline of approximately 18 migraine days per month, and were randomised to receive either subcutaneous placebo or subcutaneous AMG 334 70mg or 140mg once a month.

Across both doses, patients observed a statistically significant 6.6-day reduction from baseline in monthly migraine days compared with 4.2 days observed in those on placebo.

A reduction of 50% or more in number of monthly migraine days was observed in 40% and 41% (70mg and 140mg doses, respectively) of individuals in the AMG 334 groups, representing a significantly higher likelihood of response compared to 24% of those receiving placebo. All endpoint assessments compared the last four weeks of the 12-week treatment phase to baseline.

Other key secondary endpoint results were reductions in monthly migraine-specific medication days compared with placebo, numeric improvements in monthly headache hours compared with placebo, and improvements in quality of life improved with placebo.

The safety profile of AMG 334 was similar to placebo across both treatment arms. No adverse event was reported in greater than 5% of patients treated with AMG 334. The most common adverse events were injection site pain, upper respiratory tract infection, and nausea.

The data were presented at the European Headache and Migraine Trust International Congress (EHMTIC) in Glasgow.