A drug to prevent migraines led to three fewer days a month with the crippling headaches in a late-stage test conducted by the pharmaceutical companies Amgen and Novartis. Though that may not seem like a lot of time, it means that people could have an extra 36 days a year without a migraine.
The drug, called erenumab, is part of a new class of medications that neutralize the activity of a chemical used by nerve cells to transmit pain signals when a migraine occurs. Based on the results, it could be submitted for approval in the US and Europe as soon as next year.
Migraines — excruciating headaches that can last for days and impair a person’s life — affect 36 million Americans. That means about $20 billion a year in medical expenses and lost productivity. There’s no cure for migraines, and patients are often treated with drugs designed for other conditions, like hypertension and depression. These treatments work in only half the patients and often have terrible side effects. That’s why the new drugs, which are also being developed by several other pharmaceutical companies, are so promising.
In the latest clinical trial — the second study in the last of three phases typically required by the US Food and Drug Administration for marketing approval — patients were injected with erenumab once a month for six months. Before the trial, these patients experienced migraines about eight days a month on average. Once they were on the drug, those days with migraines decreased by an average of 3.2 to 3.7; patients in the trial’s placebo group also experienced a reduction, but only of 1.8 days. The new migraine drug’s most frequently reported side effects were upper respiratory tract infections and sinusitis.
The results are promising, but it’s hard to know specifically how the drug stacks up with other treatments. The results also represent an average, so some people likely benefitted more from the drug, while others might not have been helped at all. Identifying which groups of people respond better to the drugs is key so that the treatment can be targeted more effectively, says Elizabeth Loder, chief of the headache division at Brigham and Women’s Hospital in Boston and former president of the American Headache Society. That’s important because erenumab, like the other new migraine drugs in development, is likely to cost a lot of money.
Erenumab is a monoclonal antibody, a type of drug that’s made from living cells and is expensive to produce. It’s one of several monoclonal antibodies targeting migraines, and is expected to cost between $8,000 and $20,000 a year, according to analysts and migraine experts. That could create hurdles for patients to access the drugs; it could also mean that health insurance companies will require patients to try and fail other treatments before they’re allowed to try the antibodies.
Amgen declined to comment on the cost of erenumab. Together with two other previous clinical trials, almost 2,200 patients with chronic and episodic migraines have been treated with the drug, Amgen says. The two pharmaceutical companies plan on submitting erenumab to the FDA for approval in 2017. It’s unclear when the drug will be available to consumers.