US OK's first-in-class drug Aimovig for migraine prevention
18 May, 2018, 13:34 | Author: Sherman Richardson
The first medicine created to prevent migraines was approved by the Food and Drug Administration on Thursday, 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 has approved a new migraine drug that can cut the number of attacks patients suffer each month.
And while there aren't any drugs available today that were originally approved for alleviating migraines, other treatments - including Botox and anti-seizure medications - are used. He described it as the "first treatment directed toward migraine prevention".
The drug offers new hope for the around 39 million adults and children in the US who deal with migraines, which are characterized by an intense, pulsing or throbbing pain in one side of the head.
Migraine is three times more common in women than in men and affects more than 10 percent of people worldwide.
Patients often describe migraine headache pain as an intense pulsing or throbbing pain in one area of the head.
The attacks are triggered by a number of factors, "including stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet". It will cost $6,900 annually.
The drug named, Aimovig is given on a monthly basis by self-injections and will be priced at United States dollars 6,900 annually or USD 575 monthly.
The first study included 955 participants with a history of episodic migraine and compared Aimovig to placebo.
Alder's eptinezumab is a slightly different proposition because it is given by infusion every three months for prevention - while the other three CGRPs are all given by subcutaneously - and its delivery route means it is also being tested as an acute migraine treatment.
Erenumab consistently demonstrated an ability to reduce monthly migraine days in patients with episodic and chronic migraine in 3 major clinical trials, ARISE, STRIVE, and LIBERTY. The most commonly reported adverse events through all trials have been injection site reactions and constipation. The company found in two studies that patients on the drug had between a 3.6 and 4-day reduction in migraine days per month (to be eligible, patients had to have between 4 and 14 migraine days per month). "We need new treatments for this painful and often debilitating condition". In a third, three-month study on nearly 670 patients with chronic migraines, patients experienced on average 2.5 fewer monthly migraines.
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