Amgen’s erenumab succeeds in second phase 3 migraine study

In the global phase 3, multicenter, randomized 24-week, double-blind, placebo-controlled Strive study, 955 patients were randomized to receive once-monthly subcutaneous placebo or erenumab (70 mg or 140 mg) in a 1:1:1 ratio.

Patients receiving 70 mg and 140 mg of erenumab experienced reduction of 3.2 and 3.7 days from baseline in monthly migraine days, respectively, as compared to a 1.8-day reduction in the placebo arm.

Amgen said at baseline, patients were experiencing an average of 8.3 migraine days per month.

Erenumab, which is being co-developed by Amgen and Novartis, is a fully human monoclonal antibody specifically designed to target and block the Calcitonin Gene-Related Peptide receptor that is thought to have a key role in mediating the incapacitating pain of migraine.

It is also being tested for episodic migraine prevention and chronic migraine prevention.

Globally, about 90% of people diagnosed with migraine have episodic migraine, which is characterized by up to 14 migraine days a month, Amgen said.

Amgen research and development executive vice president Sean Harper said: "The results of this study are important because they confirm the results from our previous studies and add to our body of research in episodic migraine.

“We look forward to working with regulatory authorities to pursue approval of erenumab and making this novel migraine prevention treatment available to patients and physicians."

Amgen holds commercialization rights for erenumab in the US, Canada and Japan, and Novartis has rights in Europe and remaining parts of the world.

Image: Amgen announces Erenumab significantly reduces monthly migraine days in patients with episodic migraine in second phase 3 study. Photo: courtesy of jk1991 at FreeDigitalPhotos.net.