Progress, but not a panacea

FDA approves first drug to prevent migraines

Julia Korowski, XX2 century

American Food and Drug Administration (FDA) approved the first drug to prevent migraines. A medicine called Aimovig (erenumab) needs to be injected once a month, and this pleasure will cost $ 575 per dose. But since other companies are developing similar drugs, we can expect that the price will decrease over time.

Migraine is a serious neurological disease that manifests itself as a headache, often in one half of the head. Sometimes it is accompanied by nausea or hypersensitivity to light and sounds. Some can predict the onset of seizures in advance thanks to the "aura" – flashes of light or zigzags in front of the eyes, tingling or other tactile sensations. Migraine is not always painful for everyone, but in severe cases, seizures can cause severe pain and last for a very long time – up to 15 or even 20 days a month (in aggregate).

Aimovig is the first drug approved by the FDA not for the treatment, but for the prevention of migraines. It belongs to a new class of drugs – cocalcigenin blockers (calcitonin gene-related peptide, KGRP or calcitonin gene-related peptide, CGRP). KGRP was discovered by D. Kopp in 1961, artificially synthesized in 1968; studying this substance, researchers came to the conclusion that it plays an important role in the development of seizures. Experiments have shown that people who are prone to migraines have headaches after the introduction of KGRP. In the hope of creating a drug, pharmaceutical companies engaged in the development of antibodies.

Amgen and Novartis, who jointly developed Aimovig, were the first to finish the registration of the drug in the USA. They will sell syringe pens filled with the drug (70 and 140 mg) at a price of about $575 apiece or $6,900 per year. US citizens will probably be able to pay for Aimovig at the expense of insurance – the manufacturer assures that the price for them may drop to $ 5 per month. The medicine will be on the market in a week.

How effective is it? The FDA provides dry figures. Manufacturers conducted three clinical trials, in which 955, 577 and 677 people participated. They lasted six, three and three months, respectively. On average, patients taking Aimovig lived one to two days longer without migraines than those taking placebo. At first glance, these figures are not very impressive, but it's worth remembering this: firstly, some people are more sensitive to drugs than others, and studies show an average result. Secondly, Aimovig is only the first registered representative of this class of drugs. At least three other companies are engaged in the development of antibodies to KGRP: Teva Pharmaceutical Industries Ltd., Eli Lilly and Company and Alder Biopharmaceuticals. It is quite possible that one of them will release a more effective drug to the market. As formulated in the editorial board of JAMA magazine, new medicines are "progress, but not a panacea."

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