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September 15, 2016

Novartis’ Phase II trial of AMG 334 demonstrates significant reduction in monthly migraine days

Novartis announced the results of Phase II trial of the completely human monoclonal antibody AMG 334 (erenumab), which indicated a significant reduction in monthly migraine days when compared with the placebo in patients with a chronic migraine problem.

Novartis announced the results of Phase II trial of the completely human monoclonal antibody AMG 334 (erenumab), which  indicated a significant reduction in monthly migraine days when compared with the placebo in patients with a chronic migraine problem.

More patients receiving monthly subcutaneous AMG 334 at 70mg or 140mg experienced a 50% or more reduction in the number of monthly migraine days when compared with placebo (40%, 41% and 24%, respectively).

Novartis drug development global head and chief medical officer Vasant Narasimhan said: "These important data further support the efficacy of AMG 334 in patients who currently have limited therapeutic options.

"We are committed to continuing our work in migraine to provide a potential new treatment to patients suffering from this debilitating disease."

“We are committed to continuing our work in migraine to provide a potential new treatment to patients suffering from this debilitating disease."

The data was presented at the 5th European Headache and Migraine Trust International Congress (EHMTIC) in Glasgow, Scotland.

The trial had seen participation of 667 patients who had a mean baseline of around 18 migraine days per month. The patients were randomised to receive either subcutaneous placebo or subcutaneous AMG 334 at 70mg or 140mg once a month.

Across both these doses, the study found that patients had experienced a statistically significant 6.6-day reduction from baseline in monthly migraine days when compared with 4.2 days observed in those on placebo.

All the endpoint assessments compared the last four weeks of the 12-week treatment phase to baseline.

Further, the study found that there were reductions in monthly acute migraine-specific medication days, which were  3.5 days and 4.1 days in the 70mg and 140mg groups, respectively, when compared to a 1.6-day reduction in those receiving placebo.

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