WASHINGTON • The first medicine designed to prevent migraines has been approved by the United States Food and Drug Administration (FDA), ushering in what many experts believe will be a new era in treatment for people who suffer the most severe form of these headaches.
The FDA on Thursday issued its approval to California-based Amgen Inc, which has been collaborating with Swiss pharmaceutical firm Novartis to develop and commercialise treatments for migraines and Alzheimer's.
The drug, Aimovig, is a monthly injection with a device similar to an insulin pen. The list price will be US$6,900 (S$9,400) a year, or US$575 a month, and Amgen said the drug will be available to patients within a week.
The price applies to both a 70mg and a 140mg dose. Some Wall Street analysts had expected a price as high as US$10,000 a year.
Aimovig blocks a protein fragment, calcitonin gene-related peptide, that instigates and perpetuates migraines.
Three other companies - Lilly, Teva and Alder - have similar medicines in the final stages of study or awaiting FDA approval.
"The drugs will have a huge impact," said Dr Amaal Starling, a neurologist and migraine specialist at the Mayo Clinic in Phoenix. "This is really an amazing time for my patient population and for general neurologists treating patients with migraine."
Millions of people experience severe migraines so often that they are disabled and in despair.
These drugs do not prevent all migraine attacks, but can make them less severe and can reduce their frequency by 50 per cent or more.
As a recent editorial in the Journal of the American Medical Association put it, they are "progress, but not a panacea".
Until now, drugs used to prevent migraines were designed to treat other diseases like high blood pressure. They are not very effective, may work only temporarily and are often laden with intolerable side effects.
In clinical trials, people taking the new drugs reported no more side effects than those taking a placebo. The most common side effects reported were injection-site reactions and constipation. The side effects over the long term and among people with chronic diseases remain to be determined.
"For now, they look fantastic," Dr Stewart Tepper, a professor of neurology at Dartmouth College, said of the new drugs. "They shake the ground under our feet. They will change the way we treat migraine."
Preventive medication may be an option for around eight million Americans suffering from migraine, Amgen said. Migraine is three times more common in women than in men and affects more than 10 per cent of people worldwide.
NYTIMES, AGENCE FRANCE-PRESSE, REUTERS