Migraine Costly to Workers and Employers

By Steve Weakley

Most employees who suffer from chronic migraine headaches miss nearly a full week of work (4.6 days) due to migraines each month, according to a large new online survey.

Amgen and Novartis surveyed over 11,000 migraine sufferers in 31 countries to demonstrate how painful and costly the condition can be for both workers and employers.  The My Migraine Voice survey included people who had four or more migraine days a month.

Eighty percent of the survey takers in the U.S. said their employers knew about their migraines, but only 21 percent said their bosses offered support and understanding. Nearly two-thirds (63%) said migraines impaired their work performance and many felt judged by co-workers as a result.

"From being afraid to speak up about their disease at work in fear of losing their jobs, to feeling judged by colleagues, the stigma around migraine in the workplace is an ongoing issue that the migraine community faces daily," said Mary Franklin, executive director of the National Headache Foundation, in a press release.

"The findings from the My Migraine Voice survey shed light on the true impact of migraine at work, and showcase the urgent need for employers and employees to change the dialogue around migraine."

According to one estimate, U.S. employers lose about $11 billion a year in missed work and lost productivity because of migraines.

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Amgen and Novartis presented the survey findings at the 60th annual meeting of the American Headache Society in San Francisco, to help stir up interest in their new injectable migraine drug, Aimovig (erenumab). The FDA recently approved the monthly self-injected drug for the prevention of migraine in adults.

Aimovig uses human antibodies to target brain receptors that are thought to trigger migraines. Three clinical trials demonstrated that the drug reduced the number of migraine days for sufferers by an average of 2.5 days per month.

One obstacle in getting people to try Aimovig is its price. Amgen say the drug will cost about $6,900 a year, or $575 for each monthly dose. Amgen holds the sales rights for Aimovig in the United States, Canada and Japan, while Novartis will sell the drug in Europe and the rest of the world.

Amgen is offering a migraine management program to several large U.S. employers. The program consists of an educational program as well as a research study to document the impact of migraine on worker absenteeism, presenteeism, healthcare utilization and costs. The wellness portion of the program includes webinars, email and website tips, and a  mobile app to track migraine symptoms.

FDA Approves Injectable Migraine Drug

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a monthly self-injected drug for the prevention of migraine in adults.

Aimovig (erenumab) is the first FDA-approved migraine treatment in a new class of drugs – known as fully human monoclonal antibodies -- that target receptors in the brain where migraines are thought to originate. It blocks the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks.

"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," said Sean Harper, MD, executive vice president of Research and Development for Amgen, which shares the licensing rights to Aimovig with Novartis.

The effectiveness of Aimovig for the prevention of migraine was evaluated in three clinical trials, which found that patients experienced one to 2.5 fewer migraine days per month compared to those who took a placebo. The most common side effects were irritation at the injection site and constipation. 

Like many specialized drugs used to treat chronic conditions, Aimovig comes with a hefty price tag. Amgen says the drug will cost about $6,900 a year, or $575 for each monthly dose.

Out-of-pocket costs will vary for patients depending on their insurance. Amgen has a co-pay program for Aimovig that could reduce the cost to as little as $5 per month for eligible patients.

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The company says Aimovig will be available to patients within one week.

"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  Tepper, MD, 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."

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraine than men.

About one-third of migraine sufferers can predict the onset of a migraine because it is preceded by an aura – a 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 stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet.

Amgen and Novartis expect Aimovig to be approved in the European Union in the next few months. Amgen holds the sales rights for Aimovig in the United States, Canada and Japan, while Novartis will sell the drug in Europe and the rest of the world.

New Hope for Hard-to-Treat Migraine Patients

Amgen and Novartis have announced promising results from a Phase III clinical trial of an injectable new migraine drug called Aimovig (erenumab).

In a study of 246 patients with episodic migraine, significantly more patients injected with Aimovig had at least a 50 percent reduction in the number of monthly migraine days compared to a placebo. The study was the first of its kind to include hard-to-treat patients who have tried and failed at least two other migraine medications due to lack of efficacy or intolerable side effects.

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"We've purposely designed a clinical program for Aimovig that examined a broad spectrum of migraine patients, ranging from those who have never tried a preventive treatment to patients who have tried and failed such treatments," said Sean Harper, MD, executive vice president of Research and Development at Amgen.

"These data in patients with multiple treatment failures, who are not only considered difficult to treat but also have few options available, add to the consistent body of evidence for Aimovig.”

Aimovig belongs to a new class of medication – known as fully human monoclonal antibodies -- that target and block receptors in the brain where migraines are thought to originate. It is designed to be administered once a month with a self-injection device for migraine prevention.

"The results add to the consistent body of evidence for erenumab (Aimovig) across the full spectrum of migraine patients, from those trying preventive medication for the first time through to those who have failed multiple therapies and have been suffering for years,” said Danny Bar-Zohar, Global Head of Neuroscience Development for Novartis.

“We look forward to making erenumab, the first targeted preventive option specifically designed for migraine, available to patients as soon as possible."

Amgen and Novartis expect the Food and Drug Administration to make a decision on Aimovig in May. The two companies will share sales rights to Aimovig in the U.S. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize it in Europe and the rest of 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. Current medications to prevent migraines have been repurposed from other medical conditions, and are often associated with poor results.

Experimental Drug Reduces Migraine Days by Half

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.