Pat Anson, Editor
An experimental injectable drug reduces the number of migraine days by 50 percent or more in patients who suffer from chronic migraine, according to the results of a new study released by drug makers Amgen and Novartis.
The Phase II study of AMG 334 -- also known as erenumab – involved 667 patients who suffered an average of about 18 migraine days per month. A reduction of 50% or more in monthly migraine days was observed in four out of ten patients taking a 140 mg dose of erenumab. Patients taking a 70 mg dose had a 40% reduction in migraine days compared to a placebo drug.
Significant improvements were also noted in quality of life, headache impact, disability, and pain interference compared to the placebo.
“Chronic migraine patients lose more than half of their life to migraines with 15 or more headache days a month, facing intolerable pain and physical impairment,” said Stewart Tepper, MD, a professor of neurology at the Geisel School of Medicine at Dartmouth. “As a neurologist, these findings are exciting because they demonstrate that erenumab could serve as an important new therapy option for reducing the burden of this often-disabling disease.”
Erenumab is not an opiate and falls under a newer class of medications – known as fully human monoclonal antibodies -- that target receptors in the brain where migraines are thought to originate.
“Erenumab is specifically designed to prevent migraine by blocking a receptor that is believed to have a critical role in mediating the incapacitating pain of migraine,” said Sean Harper, MD, executive vice president of Research and Development at Amgen, which is co-developing the drug with Novartis.
“The results from this global chronic migraine study are exciting because they support the efficacy of erenumab for a patient population that has had few therapeutic options.”
Results from two Phase III studies of erenumab for episodic migraine are expected later this year. If positive results are achieved, that could lead to a new drug application with the Food and Drug Administration.
"This is an exciting time in the treatment of chronic migraine, which has a profound impact on the lives of those who suffer from the disease," said Vasant Narasimhan, Global Head of Drug Development and Chief Medical Officer for Novartis. "These important data further support the efficacy of AMG 334 in patients who currently have limited therapeutic options."
Under its agreement with Novartis, Amgen holds sales rights for erenumab in the United States, Canada and Japan, while Novartis would sell the drug in Europe and the rest of the world.
Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.