The FDA gave the go-ahead based on research showing that a single intravenous administration of the drug Vyepti (eptinezumab), once every three months, not only significantly suppresses migraine symptom frequency but also provides rapid relief soon after symptoms kick in, according to a February 21, 2020, press release from Lundbeck. The drug manufacturer expects Vyepti to be available to patients in the United States by April 2020.
Delivery Method May Explain Quick Action
For Robert Cowan, MD, professor of neurology and chief of the division of headache medicine at Stanford University in Palo Alto, California, the dual benefit of prevention and fast symptom reduction may make it an attractive choice for some migraine sufferers. “A lot of times patients come to us only when they are in the throes of a monster headache in an emergency room or urgent care basis,” says Dr. Cowan. “When you have a medication that will give them relief within one day, that’s an appealing option. It can provide some improvement from the acute headache, and then the same medication can be continued as a preventive down the road.” Peter J. Goadsby, MBBS, professor of neurology at King’s College London and University of California in San Francisco and an investigator in the clinical trial of eptinezumab, published in August 2019 in the journal Cephalalgia, suggests that the intravenous delivery method may help explain both the quick and long-lasting outcomes. “Intravenous infusion enables you to get the concentration of eptinezumab in the blood up to a peak in an optimal fashion,” Dr. Goadsby says.
Positive Outcomes for Both Episodic and Chronic Migraine
Results from two investigations guided the decision for the FDA. Published February 19, 2020, in Cephalalgia, a study of 888 patients receiving treatment evaluated the effect of the drug on episodic migraine. Episodic migraine is defined as 4 to 14 headache days a month, with at least four caused by migraine. On day one of this trial, there was a greater than 50 percent reduction in the percentage of participants with migraine symptoms compared with baseline in groups receiving either 100 milligrams (mg) or 300 mg of eptinezumab. The investigation showed that 22.2 percent of those receiving 100 mg of medication had at least 75 percent reduction in monthly migraine days at three months. That rate went up to 29.7 percent for those who received 300 mg, but was only 6.2 percent for those on placebo. Outcomes were similar in a study reported in a January 2018 press release that looking at chronic migraine, defined in the February 2020 Lundbeck press release as an average of 16 migraine days per month. Results from 1,072 individuals revealed that on day one, those people who received an infusion of eptinezumab experienced an average 52 percent reduction in migraine risk compared with 27 percent for those on placebo. A total of 26.7 percent of those receiving 100 mg of medication had at least 75 percent reduction in monthly migraine days at three months. That rate rose to 33.1 percent for those who received 300 mg, but was only 15 percent for those on placebo.
A New Safe Addition to the Therapy Tool Kit
Eptinezumab joins a growing list of CGRP (calcitonin gene-related peptide) monoclonal antibodies (a type of biological drug that targets one substance in the body) for the treatment of migraine. These other drugs include Aimovig (erenumab), Ajovy (fremanezumab-vfrm), and Emgality (galcanezumab-gnlm). These antibodies block the effect of the CGRP protein, which is highly prevalent in sensory nerves and keenly involved in pain transmission, according to an article published in 2019 in the Handbook of Experimental Pharmacology. “We have not had clear targets for our preventive therapies until these CGRP monoclonal antibodies came along,” says Goadsby. “They stop CGRP from being the bad actor in migraine. They give people a clarity of outcome that is quite unique in migraine prevention.” Previous migraine drugs have come with their share of side effects, according to Goadsby, but the CGRP inhibitors, so far, appear to have a very favorable safety profile. “One of the reasons everyone is so excited about these monoclonal antibodies is that they have so few side effects,” says Cowan.
Weighing Intravenous, Injection, and Oral Options
In general, the older CGRP options are administered by self-injection once every four weeks. For episodic cluster headache, Emgality may be taken as three consecutive subcutaneous injections of 100 mg each at the onset of the cluster period, and then monthly until the end of the cluster period, according to a press release from Eli Lilly and Company, maker of the drug. The monoclonal antibodies break down in the stomach so they are more effective when introduced directly into the bloodstream. CGRP receptor antagonists (known as gepants) are another novel type of CGRP inhibitor. These, however, can be taken orally. At the end of 2019, the FDA approved the first CGRP antagonist, Ubrelvy (ubrogepant) for immediate symptom relief. “This works by the same mechanism as eptinezumab and can stop an attack in two hours,” says Goadsby. As of now, there is no gepant available that also provides a long-term preventive effect like eptinezumab. An oral medication with this dual benefit, however, may be on the horizon. Cowan mentions that the CGRP antagonist rimegepant from the pharmaceutical company Biohaven may offer both acute and preventive treatment, per a December 2018 article in PR NewsWire. On February 27, 2020, the FDA approved Biohaven’s Nurtec ODT (rimegepant) , a quick dissolving tablet for acute migraine relief within one hour. “Many people would rather take an oral medication than go to the needle,” he says. On the other hand, Goadsby indicates that some individuals may still consider the IV a better option for receiving medication. “Some will prefer an IV once every three months because they may feel less like a patient than if they have an injection every month or take a tablet every day,” he says.
How Long Must Vyepti Be Taken, and What Does It Cost?
How long a person will need to take eptinezumab over time is still a question. “It’s impossible to tell whether a person can eventually discontinue this medication, but in general when a patient has done really well for six months or so, we look at whether we can back off medication,” says Cowan. “Sometimes that works, and sometimes it doesn’t.” While cost of the medication will depend on insurance and other factors, a spokesperson for Lundbeck told Everyday Health that the “wholesale acquisition cost” is $1,495 for the recommended dose of 100 mg of Vyepti by IV administration every three months (or $5,980 a year for four infusions of the 100 mg dose).
New Drugs Offer Hope of a Better Future for Those With Migraine
The Migraine Research Foundation estimates that about 39 million American men, women, and children experience symptoms of migraine, which can include headaches, an intense sensitivity to light, and nausea. In nearly 1 in 4 U.S. households, someone will have migraine; women and those between the ages of 18 and 44 are most commonly affected. New drugs like eptinezumab and other CGRP inhibitors offer people with migraine a pathway to a better future, according to Goadsby. “When the CGRPs work, people feel normal,” he says, “and the excitement is about this return to normality — getting back on the ship of your life in a way that they haven’t been able to do.” While the new options extend a new hope, Cowan cautions that patients still need to attend to other health fundamentals to get optimal results. “You still need to do the hard work — follow a healthy lifestyle, with regular exercise, regular sleep, a regular meal schedule, if you really want to get better,” he says.
