FDA Approves Preventative Pill for Chronic Migraine

The U.S. Food and Drug Administration (FDA) has expanded approval of QULIPTA® (atogepant) for use in preventative treatment of chronic migraine.¹ 

In a press release from manufacturer AbbVie, Chief Medical Officer, Roopal Thakkar, explains, “Since September 2021, QULIPTA has helped people living with episodic migraine prevent migraine attacks, reducing the daily burden of migraine.

Now, those with the most challenging to treat chronic migraine can also rely on QULIPTA to significantly reduce their migraine days.”¹

Atogepant is the first and only orally administered drug to target a key pathway involved in migraine pain. Most drugs that block the Calcitonin Gene-Related Peptide (CGRP) receptor are monoclonal antibodies.

These antibodies must be delivered by injection or intravenous infusion. In contrast, atogepant is a small molecule antagonist (a drug that blocks a biological response), that can be given in pill form.¹ 

“The FDA approval is an important milestone, providing those most impacted by migraine with a new, safe and effective treatment option in a convenient, once-daily pill,” says Dr. Peter McAllister, Director of the New England Center for Neurology and Headache.¹ 

Chronic migraine

The key differentiating factor between episodic and chronic migraine is the frequency of attacks.

Chronic migraine is diagnosed if a patient experiences 15 headache days per month, with at least 8 of those days meeting migraine criteria.²

Chronic migraine can be debilitating, with sufferers laid low by throbbing headaches, nausea, and light sensitivity for extended periods of time.

Many patients report a profoundly negative impact on their quality of life.³

Existing preventative drugs

CGRP antagonists have proved an effective method for preventing both episodic and chronic migraines.²   

Speaking with Medical News Bulletin, Dr. Werner Becker, Professor Emeritus of Clinical Neuroscience and Medicine at the University of Calgary, explains how beneficial these CGRP antagonists can be, even if they’re not 100% effective. “There are patients who do get a 100% response.

They are the lucky ones. Even if a smaller number get a 75% response, you still have around 50% of people who have their headache frequency cut in half”.    

Injectable monoclonal antibodies work well for many people, but an orally administered alternative is still a useful tool. Patients who are afraid of needles, can’t inject themselves, or who can’t attend monthly medical appointments to be injected or infused, will now be able to use an easy-to-take oral pill. 

Another benefit of atogepant is that it doesn’t linger in the body, eliminated within only a few days compared to the up to three months it can take for antibodies to be cleared.

Professor Becker tells us this opens avenues for women with chronic migraines who may be considering becoming pregnant.

Prospective mothers will be able to cease their treatment and clear any lingering CGRP blockers out of their system before conception in a matter of days, rather than having to wait several months. 

Oral atogepant cuts the average number of monthly headache days

Published in the Lancet, the results from the PROGRESS clinical trial, showed that those on the 60 mg dose of atogepant met the criteria for an effective treatment—a reduced average of migraine days per month.

They also saw improvements in secondary outcomes such as the average number of headache days with 40% of the participants receiving atogepant experiencing a 50% reduction in the 3-month average of migraine days.²

According to Professor Becker, this is comparable with existing antibody treatments. 

Common side effects, while generally well tolerated, include nausea, constipation, and sleepiness. 

Another tool in the box

Dr. Becker is cautiously optimistic about the future of migraine therapy, “[Atogepant is] available for episodic migraines in Canada and we hope that the chronic approval will follow.”

He further highlights the key benefit of CGRP targeting medications like atogepant, saying, “Their real strength is that they have fewer side effects than the older oral preventative medications.”

For up to 2% of the global population experiencing chronic migraines, this FDA approval expands the repertoire of medications to which they have access.

As Dr. Becker puts it, “We really can’t predict who’ll respond to one drug or another so having one more option is going to help a significant number of people and make things a little better for migraine sufferers as a whole.” 

References 

1. Newswire MP. U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine. MultiVu. Accessed August 13, 2023. 

https://www.multivu.com/players/English/9120951-abbvie-qulipta-migraine/

2. Pozo-Rosich P, Ailani J, Ashina M, et al. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. Published online July 26, 2023. http://doi:10.1016/S0140-6736(23)01049-8
3. Migraine. National Institute of Health, National Institute of Neurological Disorders and Stroke. Accessed September 2023.