FDA Approves Drug that Lowers Number of Migraine Days Per Month
The U.S. Food and Drug Administration has now a drug called erenumab-aooe and marketed as Aimovig, for the preventive treatment of migraine in adults. The self-injection drug, Aimovig, is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.
Patients often describe migraine headache as an intense pulsing or throbbing pain in an area of the brain. With additional symptoms like nausea and sensitivity to both sound and light. Roughly one-third of affected people can predict the onset of a migraine as it’s preceded by an aura – transient sensory or visual disturbances which appear as flashing lights, zig-zag lines or a temporary loss of eyesight.
Migraine is three times more prevalent in older women than in men and affects over 10 percent of individuals globally.
“Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We need new treatments for this painful and often debilitating condition.
”“Migraine is a serious neurological disease that has dramatic effects on patients’ lives. Migraine patients experience excruciating headache pain, often accompanied by other symptoms such as nausea and vomiting, and many live in constant dread of the next attack,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The FDA approval of Aimovig represents a long-awaited and important therapeutic development for patients and their physicians who are in need of additional treatment options for the prevention of migraine.”
The FDA, in a statement says three clinical trials were performed on Aimovig’s effectiveness. The very first discovered the medication reduced symptoms by a couple of days in contrast to the placebo. The next found one fewer migraine days, along with the next reporting 2.5 fewer migraine days.
“Having a treatment designed to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine. Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success,” said Stewart J. Tepper, M.D., professor of neurology at the Geisel School of Medicine at Dartmouth Medical School. “Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy – with a discontinuation rate of two percent due to adverse events – and experienced sustained migraine prevention.”
“For years, the migraine community has been advocating for new treatment options that are specifically designed to treat migraine, a debilitating and often stigmatized disease,” said Kevin Lenaburg, executive director of the Coalition For Headache And Migraine Patients (CHAMP), which represents 12 national headache and migraine patient advocacy groups. “Today we celebrate the tireless work of researchers to better understand the biology of migraine and their ability to bring a new therapeutic approach to the millions of Americans who are seeking fewer migraine days. On behalf of the community, we would also like to thank the thousands of clinical trial patients whose unwavering commitment made this progress possible.”
