New Migraine Drugs Offer Hope to Sufferers

New Migraine Drugs Offer Hope to Sufferers

Lisa DeLeonardo set a Google alert so she would know exactly when the first in a new class of migraine drugs was approved.

It happened Thursday, when the U.S. Food and Drug Administration approved Amgen and Novartis ’ application for erenumab, whose brand name is Aimovig. It’s an injectable drug touted as the first treatment designed specifically to prevent migraines, and is expected to be available to patients within a week for an annual price of $6,900. Three other similar treatments are expected to hit the market within the next year.

“I’ve been pretty desperate for this to come out and get approved,” says Dr. DeLeonardo, a 46-year-old psychologist in Delaware. “It feels the closest to kind of a miracle.”

The new treatments provide hope to the estimated 37 million people in the U.S. who suffer from migraines, predominantly women. The neurological disorder is characterized by intense, painful headaches, often accompanied by other symptoms, such as sensitivity to light and noise, and nausea.

Until now migraine patients have largely had to take drugs created to treat other diseases, such as epilepsy and high blood pressure. “What is coming is a complete change in the way we will treat migraine,” says Stewart Tepper, a neurology professor at the Geisel School of Medicine at Dartmouth. He has done consulting work for most of the companies working on the new class of drugs and was the lead investigator on the Amgen/Novartis trial with chronic migraine patients.

The new drugs are injectable antibodies that target a protein called CGRP. It’s in neurons in the brain and the trigeminal nerve, which is responsible for conveying pain messages to the brain. Researchers believe the new treatments interfere with the CGRP within the trigeminal nerve, preventing migraine pain signals from entering the brain. There are also two oral CGRP treatments in development for use when a patient has a migraine or feels one coming on.

Aimovig’s price is much higher than the inexpensive generics currently used to treat migraines, raising questions about how insurers will handle it. Ronny Gal, a senior research analyst at Sanford C. Bernstein & Co., said insurers will likely cover it but may often require patients to have tried a generic drug first. Express Scripts , a drug-benefit manager, agreed not everyone will need the drug. “We see it for people with migraine who have previously failed a preventive therapy,” says Brian Henry, a spokesman.

Amgen and Novartis say they feel confident that most insurance plans will provide coverage for adults with four or more migraines a month without requiring them to prove that they’ve unsuccessfully tried multiple other migraine medications.

Some doctors say the new treatments are over-hyped. “The treatments are only about as effective as existing treatments,” says Elizabeth Loder, a professor of neurology at Harvard Medical School and chief of the division of headache at Brigham and Women’s Hospital in Boston who wasn’t involved in any of the CGRP trials. Dr. Loder also says the long-term safety and effects of the drugs are unclear, concerns she raised in a recent JAMA editorial. Amgen and Novartis say Aimovig has been safely tested in more than 3,000 patients, with the most common reported side effects injection site reactions and constipation. Some patients are in an extended five-year trial.

‘I’ve been pretty desperate for this to come out and get approved,’ says Lisa DeLeonardo, who suffers from migraines.
‘I’ve been pretty desperate for this to come out and get approved,’ says Lisa DeLeonardo, who suffers from migraines. PHOTO: ROBERTA MOLOFF

The drugs’ proponents say they are a significant improvement over existing options, with very low side effects. Most studies have found that patients have a one in two chance of reducing migraine attacks by more than 50% and a one in three chance of having a 75% or more reduction, says David Dodick, a professor of neurology at Mayo Clinic in Phoenix and chair of the American Migraine Foundation, who has consulted with companies developing new migraine treatments.

The new drugs are for patients with episodic or chronic migraines. Patients with episodic migraines have four to 14 days with migraine headaches a month, while chronic patients have 15 days or more a month. The studies on Aimovig showed episodic migraine patients had on average three to four fewer migraine days a month, while chronic migraine patients had about six fewer migraine days a month.

Dr. Dodick notes that more than 80% of chronic migraine patients discontinue medications by a year. “Side effects are a big deal with the currently available treatments,” he says.

Such was the case for Dr. DeLeonardo, the Delaware psychologist and migraine sufferer. She had tried an anti-seizure medication commonly used with migraine patients and it helped for a few months, but side effects such as memory problems made her stop taking it. She also tried a beta-blocker, a class of drugs commonly used for high blood pressure, but it slowed her heart rate down and made it hard to exercise.

Ms. DeLeonardo enrolled in the Amgen/Novartis trial in 2015. “It was phenomenal,” she says, “and really life-changing.” She had some months with three to four migraines—compared with a dozen or more previously—and the migraines she did have were less intense.

She is concerned about the cost for the new treatments, but hopeful. “I am definitely hoping that insurance will cover much of the cost. I would not be able to afford paying thousands of dollars a year for it,” she says.


This article was originally published in The Wall Street Journal. Read the original article.

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