Silver Spring, Maryland, USA: The U.S. Food and Drug Administration, FDA, announced on Thursday that it’s approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The FDA granted the approval of Aimovig to Amgen Inc. (NASDAQ: AMGN).
The treatment is given by once-monthly self-injections. 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.
“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.” The FDA said
Patients often describe migraine headache pain as an intense pulsing or throbbing pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Approximately one-third of affected individuals can predict the onset of a migraine because it is preceded by an aura – transient sensory or visual disturbances that appear as flashing lights, zig-zag lines or a temporary loss of vision. People with migraine tend to have recurring attacks triggered by a number of different factors, including stress, hormonal changes, bright or flashing lights, lack of food or sleep and diet. Migraine is three times more common in women than in men and affects more than 10 percent of people worldwide.
The effectiveness of Aimovig for the preventive treatment of migraine was evaluated in three clinical trials. The first study included 955 participants with a history of episodic migraine and compared Aimovig to placebo. Over the course of six months, Aimovig-treated patients experienced, on average, one to two fewer monthly migraine days than those on placebo. The second study included 577 patients with a history of episodic migraine and compared Aimovig to placebo. Over the course of three months, Aimovig-treated patients experienced, on average, one fewer migraine day per month than those on placebo. The third study evaluated 667 patients with a history of chronic migraine and compared Aimovig to placebo. In that study, over the course of three months, patients treated with Aimovig experienced, on average, 2 ½ fewer monthly migraine days than those receiving placebo.
The most common side effects that patients in the clinical trials reported were injection site reactions and constipation.
Amgen set a $6,900 annual price for its drug, or $575 a month. The company said late Thursday that the drug will become available within a week.
Because the drug is a preventative medicine for a chronic condition, a patient would need to take the drug on a regular basis, perhaps for life. While physicians and industry observers welcome a new approach to treating migraine, some have expressed concerns about the cost of the Amgen drug and others in its class.
“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.”
With FDA approval in hand, the Amgen drug will be the first CGRP-targeting medicine to reach the market. Other drugs that work in a similar way could soon follow. The Eli Lilly (NYSE: LLY) drug galcanezumab, also a monthly subcutaneous injection, is expected to receive an FDA decision in the third quarter of this year. The FDA was scheduled to issue a decision in June for the Teva Pharmaceutical (NYSE: TEVA) drug fremanezumab, a drug injected once every three months. But that drug faces a likely delay due to problems that the FDA found with a third-party manufacturer that Teva uses to make the product.
A fourth migraine-preventing drug, eptimezumab, has completed late-stage testing for both episodic and chronic migraines. Its developer, Bothell, WA-based Alder BioPharmaceuticals (NASDAQ: ALDR), plans to file for FDA approval early next year.
The Amgen drug’s late-stage clinical development was financed in part by Novartis. In 2015, when the drug was about to start Phase 3 testing, Novartis licensed rights to the compound outside of the U.S. and Japan. The deal also included rights to other migraine drugs in Amgen’s pipeline. In exchange, Novartis agreed to finance additional R&D for erenumab, and to pay royalties on sales of the drug if it reached the market. In addition to its review by the FDA, the drug is currently being evaluated by regulators in Europe.
Last year, Amgen and Novartis entered into a partnership to sell erenumab. The companies will work together to sell the drug in the U.S. Amgen keeps rights to the drug in Japan, while Novartis holds drug marketing rights in the rest of the world. If the drug hits development and regulatory targets, Amgen stands to gain more than $400 million in milestone payments from Novartis.
“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.”
“In addition to bringing a new therapeutic option to patients in the U.S., Amgen also has a commitment to reshape the public’s perception of this stigmatized disease,” said Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen. “We have pledged a mission to help change misconceptions, stereotyping and even judgment that people with migraine face on a daily basis. Through educational programs and initiatives, we hope to promote more meaningful connectivity and dialogue among patients, physicians, employers and payers.”
The European Medicines Agency (EMA) Marketing Authorization Application (MAA) for Aimovig is under review. The companiessaid they expect approval in the EU in the coming months.
People with frequent migraine may lose more than half their life to migraine. They endure debilitating pain, physical impairment, and live in constant dread of the next attack – all of which is compounded by a widespread misperception of the disease.2 The 2016 Global Burden of Disease Study ranks migraine among the top 10 causes of years lived with disability worldwide.3 Migraine is associated with personal and societal burdens of pain, disability, and financial cost, and it remains under-recognized and under-treated.
According to the National Institutes of Health (NIH), the pain of a migraine headache is often described as an intense pulsing or throbbing pain in one area of the head. However, it is much more; the International Headache Society diagnoses a migraine by its pain and number of attacks (at least 5, lasting 4-72 hours if untreated), and additional symptoms including nausea and/or vomiting, or sensitivity to both light and sound. Migraine is three times more common in women than in men and affects more than 10 percent of people worldwide. Roughly one-third of affected individuals can predict the onset of a migraine because it is preceded by an “aura,” visual disturbances that appear as flashing lights, zig-zag lines or a temporary loss of vision. People with migraine tend to have recurring attacks triggered by a number of different factors, including stress, anxiety, hormonal changes, bright or flashing lights, lack of food or sleep, and dietary substances. Migraine in some women may relate to changes in hormones and hormonal levels during their menstrual cycle. For many years, scientists believed that migraines were linked to the dilation and constriction of blood vessels in the head. Investigators now believe that migraine has a genetic cause, the NIH says.
Migraines affect more than 38 million people in the U.S., and more than 1 billion people worldwide, according to the pharmaceutical industry-funded Migraine Research Foundation. An estimated 90 percent of migraine sufferers have episodic migraine, ranging from five to 14 headaches per month. Between 5 and 8 percent, have chronic migraine, defined as more than 15 headaches per month.