US FDA APPROVES WORLD’S FIRST MEDICINE TO PREVENT CHRONIC MIGRAINES
WASHINGTON: The US drug regulator has approved for sale the firstever 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 on Thursday 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-amonth 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.”