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Friday, Dec 13, 2019

US approves world’s first migraine-prevention drug for sale, no plans yet for India

Aimovig works by blocking the activity of the calcitonin gene-related peptide, a molecule responsible for migraine attacks. Three clinical trials showed participants administered with the drug suffering significantly fewer episodes of migraine than those on placebos.

world Updated: May 18, 2018 09:22 IST
Yashwant Raj
Yashwant Raj
Hindustan Times, Washington
Migraine is three times more common among women than men.
Migraine is three times more common among women than men.(HT File)

The US drug regulator on Thursday announced that it has approved for sale the first-ever medicine that prevents migraine, a debilitating headache which can last from hours to days. One in 10 people across the world are afflicted by this ailment.

The US Food and Drug Administration (FDA) said that the drug — Aimovig — works by blocking the activity of the calcitonin gene-related peptide, a molecule responsible for migraine attacks. Developed by Novartis and Amgen, Aimovig will go on sale in the United States within a week at a cost of $575 for a once-a-month self-administered injection, according to one of the companies.

The approval for sale in the European Union is expected in the next few months. There was no response from either company to questions about sales plans for India, which remains a low-priority market for new medicines from western pharmaceutical companies that expect a higher selling price to compensate for research-related investments. At the heart of this problem is an unresolved conflict between the business of pharmaceuticals driven by the discovery of new drugs through expensive research and the social and moral responsibility felt by emerging economies such as India to extend affordable medicine to all.

More than 10% of the people worldwide are affected by migraine, which can also be accompanied by other symptoms such as nausea, vomiting and extreme sensitivity to light and sound. The condition is three times more common among women than men.

“Aimovig provides patients with a novel option for reducing the number of days (spent suffering) with migraine,” said Eric Bastings, 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.”

Three other companies with matching medicines that use the same molecule blocker have also reached the final stages of the FDA’s approval process. Aimovig is only the first out of the gate.

The US regulator said the effectiveness of the new drug was tested in three clinical trials. In all instances, participants administered with Aimovig suffered significantly fewer episodes than those on placebos. However, there were side-effects too – namely injection-site reactions and constipation.

Amgen, an American company based in California, said a study in difficult-to-treat patients — those with episodic migraines who failed two to four prior treatments – showed that those given Aimovig had nearly three-fold higher odds of having their migraine days cut by half or more as compared to placebos.

Until now, medicines prescribed to migraine patients included those used for other ailments such as blood pressure as well as others known to cause severe side-effects. But it’s known well among the migraine-afflicted that there is not medicine to treat or prevent these severely debilitating episodes that some patients can see coming. “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,” the FDA said in its statement.

The attacks are triggered by a number of factors, “including stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet”.