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THOUSAND OAKS, Calif.—Aimed at relieving the debilitating pain of chronic migraine sufferers, Amgen has partnered with Basel, Switzerland-based Novartis to come up with a novel treatment from Amgen’s clinical study program, which has shown evidence of the efficacy of Aimovig (erenumab) for migraine prevention. Erenumab is reportedly the first and only investigational biologic product specifically designed to prevent migraine by blocking the calcitonin gene-related peptide receptor—a trigger to activating migraine.
The rationale for pursuing this route for migraine treatment largely comes out of a pivotal Phase 2 chronic migraine study by Amgen demonstrating that erenumab reduced the number of monthly migraine days in patients who failed previous preventive therapies.
“Data from our robust clinical development program continue to show that erenumab has demonstrated efficacy in a broad range of patients, including hard-to-treat chronic migraine sufferers who have previously tried and failed other preventive therapies,” said Dr. Sean E. Harper, executive vice president of research and development at Amgen. “Separately, new results from a treadmill safety study showed no adverse cardiovascular effect compared to placebo in patients with coronary artery disease and stable angina, which complements our extensive safety database and ongoing long-term extension studies [of erenumab] for migraine prevention.”
“Migraine is ranked one of the most debilitating diseases by the World Health Organization, yet it is often under-diagnosed and under-treated,” he adds. “People who experience migraine, battle the disease for many years with significant impact on their everyday activities.
“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.”
With regulatory submissions for erenumab filed in the United States and Europe, the FDA has set a Prescription Drug User Fee Act target action date of May 17, 2018. If approved, Novartis and Amgen will get the green light to co-commercialize erenumab in the United States. Amgen has exclusive commercialization rights to the drug in Japan, while Novartis gets exclusive rights to commercialize in the rest of world.
“This partnership was driven by our collective commitment to marry Novartis’ almost 70 years of experience in neuroscience with Amgen’s biologics expertise to help advance scientific discovery in migraine,” Dan Bar-Zohar, global head of neuroscience development at Novartis, tells DDNews.
Novartis has designed and is conducting an ongoing clinical trial in episodic migraine patients that have had multiple prior treatment failures, Bar-Zohar says. This extends beyond the data presented at the International Headache Society Congress (IHC) 2017, which showed that erenumab delivered consistent reductions in monthly migraine days for patients with chronic migraine and prior treatment failure.
According to Bar-Zorah, “A very well received oral presentation at IHC (Sept. 7-10, 2017) from a safety study assessing erenumab 140 mg in a population of patients with stable angina, showed that erenumab had no adverse impact on ability to undergo cardiac stress test.
“Now is an exciting time in migraine prevention research, overall. Novartis and Amgen are leading the way with erenumab which has the potential to offer patients the first-ever specifically designed treatment for migraine prevention, representing the biggest advance in migraine management in almost a decade.”
Up to 80 percent of people with migraine discontinue preventive treatment within one year. However, the Phase 2 study has shown erenumab appeared to prevent another migraine from occurring longer. At the end of a 12-week study, patients who had failed two or more prior preventive treatments experienced a reduction of 7.0 days and 5.4 days in the erenumab 140 mg and 70 mg, respectively, compared to placebo reduction of 2.7 days.
Furthermore, in the erenumab treated arms, the odds of cutting migraine days in at least half was three- to four-fold higher than in the placebo arm (140 mg: 41.3 percent, 70 mg: 35.6 percent, placebo: 14.2 percent).
The safety profile of erenumab was similar to placebo across both treatment arms in the Phase 2 study. No adverse event was reported in greater than 5 percent of patients treated with erenumab, with the most common being, injection site pain, upper respiratory tract infection and nausea.
Erenumab was also tested in a group of patients with stable angina due to coronary artery disease. A treadmill “stress test” is often used to gauge how well a patient’s heart can handle exercise. The study met it primary endpoint of non-inferiority, showing no difference in exercise time among participants receiving erenumab or placebo.
Erenumab has been studied in several large global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention. More than 2,600 patients have been exposed to erenumab across the four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extension.
“We look forward to continuing our legacy in neuroscience through our collaboration with Amgen and working with health authorities on our goal to make our fully human monoclonal antibody, erenumab, the first new preventive therapy available to migraine patients in almost a decade,” Bar-Zorah concludes.