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FDA approves migraine medicine – WSJ



The Food and Drug Administration approved a new drug against migraine on Thursday

Amgen
Inc.

Y

Novartis
AG

What doctors say can change the lives of patients by decreasing the number of days of migraine that patients suffer each month.

In three clinical trials, it was shown that the drug, called Aimovig, is better than placebo in reducing the incidence of migraines. [19659004] Migraines can be debilitating, causing pain for hours or even days. They are often accompanied by nausea, vomiting or extreme sensitivity to light and sound.

For people suffering from migraines, the new medication seems to be potentially a powerful relief.

"We believe that it will revolutionize treatment in migraines", said

Tareck Kadrie,

a neurologist in private practice in Chattanooga, Tenn. He described the drug as the "first treatment aimed at the prevention of migraine".

Currently, Dr. Kadrie said, doctors tend to use medications like blood pressure and seizure medications that "happen to prevent migraines."

It is estimated that in the USA. In the United States, more than 37 million people suffer from migraines, and studies suggest that up to 13% of the adult population in the United States. UU they have them, including two million to three million who are chronically ill. The condition tends to be approximately three times more frequent in women than in men, and is especially prevalent in the age group between 35 and 55 years.

The data presented by the companies suggest that the new drug could eliminate some days of migraines each month. The drug was studied in three clinical trials. In the first, Aimovig was evaluated in 955 patients with a history of migraines. Patients who took the medication suffered from one to two days of migraine per month less than those who took placebo.

"This does not sound like a big problem for someone who does not suffer from migraines," Dr. Kadrie said, but stressed that's it.

Dr.

Zubair Ahmed,

A headache specialist at the Cleveland Clinic said: "We know that there is no treatment that is a cure for migraine because it is a chronic disease, but this may be another step in that direction."

In another clinical study, comparing the drug again with placebo, 577 patients during three months had, on average, one day less migraine per month. In the third study, the comparison was approximately 2 1/2 fewer days of migraine per month.

The treatment is taken once a month by self-injection. Medicine is part of a new class of drugs that work by blocking the action of a molecule involved in migraine, known as a peptide related to the calcitonin gene.

"Aimovig provides patients with a novel option to reduce the number of days with migraine," he said.

Eric Bastings,

Deputy Director of the Neurology Products Division at the FDA Drug Evaluation and Research Center. "We need new treatments for this painful and often debilitating condition."

The condition appears frequently from childhood, adolescence, or the beginning of adulthood.

In many cases, the onset of migraine is preceded by what is called aura, although many people do not experience it.

Auras involve symptoms such as visual disturbances, including wavy vision or flashes of light. They may also involve sensory, movement or speech disorders and muscle weakness.

Amgen said it plans to charge $ 6,900 annually for the drug, and that it will be available in about a week.

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