Head-to-Head Migraine Study Ends in Tie

By Pat Anson, PNN Editor

An unusual head-to-head competition between two migraine prevention drugs has ended in a virtual tie. There were no substantial differences in effectiveness between Emgality and Nurtec, according to preliminary results from a clinical trial released by Eli Lilly, the maker of Emgality.

Emgality and Nurtec both inhibit calcitonin gene-related peptides (CGRP), a protein that causes migraine pain, but their delivery systems are different. Emgality is injected once a month, while Nurtec is an oral medication taken every other day made by Biohaven Pharamceuticals, a subsidiary of Pfizer.

Eli Lilly launched the trial in late 2021, enrolling 575 participants in a Phase 4, double-blind, placebo-controlled study evaluating the efficacy and safety of Emgality (galcanezumab) and Nurtec (rimegepant) for 3 months in adults with episodic migraine.

The so-called CHALLENGE-MIG trial was a bold and somewhat risky move by Lilly, as it seeks to gain more market share in the highly competitive $2 billion U.S. migraine market.

In a statement, Lilly said Emgality did not meet the study's primary goal, which was statistical superiority to Nurtec in achieving at least a 50% reduction in monthly migraine headache days. The response rates of patients and safety profiles of both drugs were similar.

Lilly said Emgality was superior to Nurtec in some secondary outcomes, but didn’t disclose what they were. The company would only say that Emgality helped prevent migraines, as it has in previous studies.  

"These results bolster our knowledge of Emgality's ability to work quickly and help patients improve their quality of life with less frequent dosing," Anne White, executive vice president of Eli Lilly, said in a press release. "Reducing the frequency of migraine headache days can help people experience more freedom from the burden of this debilitating neurological disease and get back to participating in the daily activities that matter most to them."

Final result from the CHALLENGE-MIG trial won’t be posted until later this year.

“Nurtec ODT is the first and only medication approved as both an acute treatment for migraine and a preventive treatment for episodic migraine in adults. It offers flexibility to patients in treating their migraines and is the leading prescribed oral CGRP receptor antagonist,” Pfizer said in a statement. “We are confident in the efficacy and tolerability profile of Nurtec ODT as demonstrated in the clinical trials and the well-established patient preference for oral agents over injectables.

First approved by the FDA in 2018, CGRP inhibitors are the biggest innovation in migraine treatment in decades. They are also expensive, whether taken by pill or injection.

The listed cash price for Emgality is $679 for a single injection or $8,148 annually; while 8 tablets of Nurtec cost $1,011 or about $23,000 a year. Costs to patients will vary, depending on insurance coverage, copay assistance programs and rebates.

Unusual Head-to-Head Migraine Study Pits Emgality vs. Nurtec

By Pat Anson, PNN Editor

Competition has grown intense between pharmaceutical companies in the $2 billion U.S. migraine market.

You’ve probably seen their TV commercials. Eli Lilly hired Olympic athletes to pitch Emgality, an injectable migraine preventative, while reality star Khloé Kardashian is appearing in commercials for Nurtec, an oral medication made by Biohaven Pharamceuticals

Lilly is now taking the competition a step further, with an unusual head-to-head clinical study – rare in the pharmaceutical industry – that pits Emgality against Nurtec. The company is enrolling 700 adults with episodic migraine in a randomized, double-blind, placebo-controlled trial. The so-called CHALLENGE-MIG study will directly compare the efficacy and safety of the two drugs.

“Lilly’s CHALLENGE-MIG study will help us understand how different types of preventive medications may help people achieve the goals that matter most to them. It’s exciting that insights generated in this first-of-its-kind head-to-head trial will be able to spark treatment plan discussions between people with migraine and their health care providers,” Shivang Joshi, MD, a trial investigator at Dent Neurologic Institute, said in a Lilly press release.

Emgality and Nurtec both inhibit calcitonin gene-related peptides (CGRP), a protein that causes migraine pain, but their delivery systems are very different. Emgality is injected once a month, while Nurtec is taken in a pill every other day.

Emgality was one of the first CGRP inhibitors to be approved by the FDA in 2018, while Nurtec is a relative newcomer, first approved in 2020. Nurtec’s label was recently expanded to include both migraine prevention and treatment.

The primary goal of the Lilly study is to see which drug gives patients a greater reduction in monthly headache days, with a secondary goal of measuring quality of life improvements.

“We believe patients should expect more and get more from medications that can help prevent migraine. Therefore, we look forward to sharing the findings from our Emgality versus Nurtec ODT head-to-head trial,” said Anne White, senior vice president of Eli Lilly and president of Lilly Neuroscience.

Biohaven’s CEO welcomes the study and sees it as an affirmation of Nurtec’s growing share of the market. Since it was introduced last year, Nurtec has generated about $200 million in revenue for Biohaven, with over 750,000 prescriptions filled. 

"This new head-to-head trial affirms that Nurtec ODT is perceived as the new standard of care.  The dual-therapy action of Nurtec ODT is unique and provides clear advantages to both treat and prevent migraine attacks.  Since the launch of oral acute CGRP agents, the performance of injectable CGRP (inhibitors) is now negligible to flat,” Vlad Coric, MD, CEO of Biohaven Pharmaceuticals, said in a statement to PNN. 

“Regardless of this Emgality study outcome, the Nurtec ODT value proposition will not be matched. And Nurtec ODT will have an impressive and entrenched market penetration by the completion of the proposed head-to-head study.  We continue to hear from patients, who want oral over needle-based therapies.” 

Regardless of whether it’s a pill or injection, both drugs are expensive. A supply of eight Nurtec tablets costs about $941, depending on insurance coverage. The listed price for Emgality is $627 for a single injection or about $7,524 annually.

If you’d like to know more about the study or possibly enroll in it, call the Lilly Answers Center at 1-800-545-5979.

FDA Approves Another Expensive Migraine Drug

By Pat Anson, PNN Editor

The highly competitive and lucrative market for migraine drugs will grow more crowded this month when AbbVie introduces Qulipta (atogepant), an oral CGRP medication developed for the prevention of episodic migraines.

The Food and Drug Administration approved Qulipta after seeing the results of a Phase 3 clinical trial that found the drug was 50 to 100% effective in preventing migraines.

"During the trial while taking Qulipta, I had many fewer migraine days. For the first time ever, I don't have difficulty doing my daily activities and I don't have to worry as much that a migraine attack will cause me to miss important events with family and friends," said Kelsi Owens, a trial participant who has lived with migraine for nearly three decades.

Like other CGRP inhibitors, Qulipta blocks proteins called calcitonin gene-related peptides from binding to nerve receptors in the brain and causing migraine pain. Since 2018, the FDA has approved over half a dozen CGRP medications, most of which are injected monthly.

Qulipta is a pill meant to be taken daily that comes in three different doses. Like other CGRP inhibitors, Qulipta is expensive. The wholesale price for a patient without insurance is $991 for 30 pills, according to Abbvie. Insured patients or those enrolled in an AbbVie patient support program will pay less.     

"Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients," said study investigator Peter Goadsby, MD, a neurologist and professor at University of California, Los Angeles. “I'm particularly encouraged by the convenience of the oral daily use of Qulipta, its rapid onset of significant efficacy, and its safety and tolerability as well as its high patient response rates.”   

Qulipta is expected to compete directly with Nurtec, an oral CGRP inhibitor made by Biohaven Pharmaceuticals that is approved for both migraine prevention and treatment. A supply of eight Nurtec tablets costs about $941, depending on insurance coverage. Since it was introduced in 2020, Nurtec has generated about $200 million in revenue for Biohaven, with over 750,000 prescriptions filled.

AbbVie says Qulipta will be available in early October. Wall Street analysts project Qulipta sales will reach $1 billion by 2030.

Side effects from Qulipta include nausea, constipation, fatigue and loss of appetite. AbbVie is currently conducting a clinical trial to seek if Qulipta should also be approved for the prevention of chronic migraine – patients who have 15 or more headaches per month.

Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

FDA Approves First Drug for Both Migraine Treatment and Prevention

By Pat Anson, PNN Editor

Migraine sufferers have a new medication that not only treats migraines, but can also be used to help prevent them. Biohaven Pharmaceuticals announced this week that Nurtec (rimegepant) -- a drug already being used to treat migraine pain – has been approved by the FDA as a migraine preventative, making it the first migraine medication that can be used for both treatment and prevention.

Nurtec is a calcitonin gene-related peptide (CGRP) inhibitor, a relatively new class of medication that blocks a protein released during migraine attacks from binding to nerve receptors in the brain. Since 2018, the FDA has approved a handful of CGRP medications, most which are taken by injection.

Nurtec is a quick-dissolving tablet that is taken orally. A single dose can treat migraine pain for up to 48 hours. The expanded FDA approval means Nurtec can now also be taken daily or every other day to help reduce the frequency of migraines. 

“The FDA approval of Nurtec ODT for the preventive treatment of migraine -- along with its acute treatment indication -- is one of the most groundbreaking things to happen to migraine treatment in my 40 years of practicing headache medicine. To have one medication patients can use to treat and prevent migraine will likely change the treatment paradigm for many of the millions of people who live with migraine," said Peter Goadsby, MD, a Professor of Neurology at the University of California, Los Angeles.

Goadsby was one of the investigators in a Phase 3 study that helped prove Nurtec can be used as a migraine preventive. In findings recently published in The Lancet, Nurtec reduced the number of migraine days per month by 30% after one week of treatment. After three months of treatment, about half of the patients taking Nurtec had at least a 50% reduction in the number of moderate-to-severe migraine days per month.

Nurtec was well-tolerated by most patients during the clinical trial. Some reported nausea, stomach pain and indigestion.

"This FDA approval marks the beginning of a new era for migraine treatments, allowing the potential for healthcare professionals to prescribe, and patients to have, a single medication to treat and prevent migraine attacks,” Biohaven CEO Vlad Coric, MD, said in a statement. “This groundbreaking approach to treating the full spectrum of migraine disease, from acute therapy to prevention, can have a significant impact in a patient's life by helping to decrease treatment plan complexity and reduce challenges with adherence and polypharmacy.”

One obstacle to using Nurtec is its cost. Currently, a single 75mg tablet is priced at about $117. A supply of eight tablets is around $941, depending on your insurance coverage and pharmacy.  Biohaven has a patient assistance program that can help some patients who lack insurance or can’t afford the drug.

A recent survey of nearly 4,700 migraine patients by Health Union found that about one in four (26%) are currently using a preventive CGRP medication. About 11 percent said they were using a CGRP to treat migraine pain. Patients who did not try the drugs said they were concerned about side effects, long-term safety and their cost.

Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

Survey Finds Patients Wary of Trying CGRP Migraine Drugs

By Pat Anson, PNN Editor

Khloe Kardashian and Serena Williams have their work cut out for them. Despite their endorsement of a new type of migraine medication, many patients remain wary of the drugs and few have tried them, according to a large new survey.

The annual survey of nearly 4,700 migraine patients by Health Union found that about one in four (26%) are currently using a preventive CGRP medication, down from 29% in last year’s survey. And only 11 percent of patients said they were using a CGRP to treat migraine pain.

CGRP stands for calcitonin gene-related peptides, a protein that binds to nerve receptors in the brain and triggers migraine pain. Since 2018, the FDA has approved four injectable CGRP inhibitors (Aimovig, Ajovy, Emgality, Vyepti) to prevent migraine and two CGRP tablets for acute migraine (Ubrelvy, Nurtec). The latter two were recently endorsed by reality star Kardashian and tennis star Williams.   

Although Eli Lilly, Teva, Amgen, and other drug companies have aggressively marketed CGRP medications and even given the drugs away for free to get people to try them, sales growth has been slow. Only Aimovig and Emgality are used by at least 10 percent of migraine patients.

PERCENTAGE OF PATIENTS CURRENTLY USING CGRP INHIBITORS

SOURCE: HEALTH UNION 'MIGRAINE IN AMERICA 2020'

Most migraine patients continue to rely on older and cheaper medications such as triptans, anti-depressants, anti-convulsants, over-the-counter drugs, and Botox injections.

The Health Union survey helps explain why. While most patients are aware of CGRP inhibitors and nearly half (43%) had tried a preventive CGRP, most stopped taking them after trying just one brand. That’s not uncommon for migraine sufferers, who often have try multiple treatments before finding one that works.   

“Everybody’s experience with treatment is different. And the fact that there are multiple brands available is actually a really good thing. Because some of them just happen to work better for some people than others,” says Brian Green, Health Union’s vice-president of community business solutions.

CGRP’s do work for some patients. The Health Union survey found that 58% of patients currently using a preventive CGRP reported having less head pain. And nearly half said they didn’t react as strongly to migraine triggers such as loud noises and bright light.  

Those who had heard of preventive CGRP medications but had not tried them cited a number of reasons:

• 44% Doctor has not recommended it

• 27% Concerned about side effects

• 21% Concerned about long-term safety

• 19% Can’t afford them

• 14% Insurance won’t cover

CGRP medications are not cheap. Eight doses of Nurtec, the acute CGRP endorsed by Kardashian, can cost over $1,000 without insurance.

Nearly half the patients surveyed said they were still using triptans or over-the-counter pain medication for migraine relief. Antidepressants and Topamax were the most commonly used medications for migraine prevention. 

Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.