New Migraine Drug Has Drawbacks

The FDA has just approved a new, first-of-its-kind drug designed to prevent migraines. It comes in the form of an auto-injector (you stab yourself once a month) for a list price of $ 575 a piece. In a sad commentary on US drug prices, this is a cheaper price than investors expected . Meanwhile, people with r / migraines say it’s not much more expensive than other medications they are already taking.

The new drug, Imovig, is an antibody , just like the antibodies that our immune systems make to attack viruses and other attackers. These antibodies were made in a laboratory and are designed to stick to receptors in our body that would otherwise interact with a protein called CGRP . It is unclear what exactly CGRP does or why levels rise during migraines. Amgen, the manufacturer of Aimovig, summarizes the current state of knowledge on its website : “There may be a link between CGRP, CGRP receptors and migraine.”

Much is still unknown. Aimovig’s patient information says that no one knows if it is safe to use the drug if you are pregnant or breastfeeding. Elizabeth Loder , a neuroscientist at Harvard, noted in a tweet that one of the conditions for Aimovig’s FDA approval was that the company should investigate whether people taking the drug are at greater risk of liver poisoning, heart attacks, and stroke.

If your migraine is severe enough, the medication may be worth it. Amgen believes it can cover the drug with most insurances for people with at least four migraines a month, and is proposing lower patient co-payments (they told investors there would be a $ 5 co-payment program) to encourage people to ask for the drug while still forces insurance companies to pay most of the bills. On Aimovig site in a two-month free trial is now also advertised version for new patients.

However, this is not a miracle drug. The Aimovig website reports that people with chronic migraines have six to seven days fewer migraines per month, but people who took a placebo in the same study (injections without drugs) also had fewer migraine days. The FDA ad compares numbers to the placebo group in each study, which is the right way to do it. In three studies, people averaged one fewer migraines per month, one to two days less, or (for people with the most frequent migraines) two and a half fewer.

However, these are averages, and they hide something very important: 40 percent of migraine patients in trials received a huge reduction in the number of migraine days – 50 percent or better. If you are one of those people, great! And if you’re one of the 24 percent who had the same reduction in the placebo group, I’m happy for you, too. But for some people to have such a strong reaction, others must have had no effect or very little influence. So the chances are that some of the people who (get their insurance) pay $ 575 a month for this drug may not get any benefit at all. There is no way yet to know which group you will fall into before you try.

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