U.S. FDA Approves Qulipta (atogepant) for Adults With Chronic Migraine

NORTH CHICAGO, Ill., April 17, 2023 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved expanding the indication of Qulipta (atogepant) for the preventive treatment of migraine in adults. The approval makes Qulipta the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. People living with chronic migraine experience headaches for 15 or more days per month, with at least eight of those days associated with migraine.1

“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,” said Roopal Thakkar, senior vice president, chief medical officer, AbbVie. “This approval makes AbbVie the only company with three treatments across the spectrum of migraine, including Qulipta as a preventive treatment for both episodic and chronic migraine; Botox® (onabotulinumtoxinA), our foundational, first FDA-approved preventive treatment for chronic migraine; and Ubrelvy® (ubrogepant), an acute treatment for migraine attacks.”

Qulipta’s expanded chronic migraine indication is based on the pivotal Phase 3 PROGRESS trial evaluating Qulipta 60 mg once daily in adult patients with chronic migraine, which met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period.2 The average monthly migraine days (MMDs) for patients at baseline during the clinical trial was 19.3 The trial also demonstrated that treatment with Qulipta resulted in statistically significant improvements in all six secondary endpoints.3 This includes key secondary endpoints that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period and improvements in function and reduction in activity impairment due to migraine.4 These efficacy results are consistent with those in the ADVANCE episodic migraine trial.5

“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,” said Peter McAllister, M.D., Director of the New England Center for Neurology and Headache. “Qulipta’s data demonstrate that it helps reduce the burden of migraine by delivering improvements in function, with high response rates and sustained efficacy over 12 weeks. These are critical factors neurologists and headache specialists consider when prescribing a treatment option, particularly for those with chronic migraine.”

Qulipta blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of Qulipta is indicated for the preventive treatment of chronic migraine. The overall safety profile of Qulipta is consistent with the episodic migraine patient population, with the most common adverse events including constipation, nausea and fatigue/sleepiness.6

“For years, I felt hopeless and struggled to find a treatment that not only reduced the number of migraine attacks but could also help reduce how often migraine impacted my daily activities like taking my kids to school or practices,” said Latoya Lawrence, a patient who has lived with migraine for more than 20 years. “After I started taking Qulipta for my episodic migraine, I wasn’t as worried about when my next migraine attack might strike. I’m glad people living with chronic migraine now have a treatment option that has the potential to make a substantial impact on their lives.”

About the Phase 3 PROGRESS Clinical Trial

The Phase 3 PROGRESS clinical trial evaluated the safety, tolerability and efficacy of oral Qulipta 60mg once daily (QD) for the preventive treatment of chronic migraine.7 The patient population for the study included patients with a diagnosis of chronic migraine for at least one year, and greater than or equal to 15 headache days with greater than or equal to eight migraine days in the 28 days prior to randomization.7 The primary endpoint measured the reduction from baseline in mean monthly migraine days compared to placebo across a 12-week treatment period.7

Key secondary endpoints across the 12-week treatment period included: change from baseline in mean monthly headache days; change from baseline in mean monthly acute medication use days; proportion of participants with at least a 50% reduction in mean monthly migraine days; and change from baseline in Migraine Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive domain score at Week 12. The MSQ v2.1 is a questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past four weeks. Key secondary endpoints also included change from baseline in Activity Impairment in Migraine-Diary (AIM-D) Performance of Daily Activities and Physical Impairment domain scores. The AIM-D is a novel questionnaire designed to evaluate difficulty with performance of daily activities and physical impairment due to migraine.

About Qulipta® (atogepant)

Qulipta® is approved by the U.S. Food and Drug Administration (FDA) and is available in the United States for the preventive treatment of migraine in adults. Qulipta is the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology, and studies have shown that CGRP levels are elevated during migraine attacks. Qulipta blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of Qulipta is approved for the preventive treatment of chronic migraine.


Do not take Qulipta if you have had an allergic reaction to atogepant or any ingredients in Qulipta.

Before taking Qulipta® (atogepant) tablets, tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Qulipta may affect the way other medicines work, and other medicines may affect how Qulipta works. Your healthcare provider may need to change the dose of Qulipta when taken with certain other medicines.

Qulipta can cause serious allergic (hypersensitivity) reactions, like anaphylaxis, that can happen when you take Qulipta or days after. Stop taking Qulipta and get emergency medical help right away if you get any of the following symptoms, which may be part of a serious allergic reaction: swelling of the face, lips, or tongue; itching; trouble breathing; hives; or rash.

The most common side effects of Qulipta are nausea, constipation, and fatigue/sleepiness. These are not all the possible side effects of Qulipta.

About Migraine and Chronic Migraine

Migraine is a complex neurological disease with recurrent attacks that are often incapacitating and characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea.8 It is highly prevalent, affecting more than 1 billion people worldwide, including nearly 40 million people in the United States alone, and is the highest cause of disability worldwide for people under 50 years of age.9-12

People living with chronic migraine experience headaches or migraine for 15 or more days per month, with at least eight of those days associated with migraine.13 It is differentiated from episodic migraine, which is characterized by 0-14 headache days per month,14 by its more debilitating disease profile including greater prevalence of comorbid conditions as well as higher frequency of headache and migraine days.14-16 Individuals with chronic migraine experience frequent disabling migraine attacks, preventing them from performing daily activities and significantly affecting their quality of life. This results in substantial societal and familial burden.17-21 Significant direct and indirect costs are also associated with chronic migraine, leading to economic burden for patients and healthcare systems.22-24

About AbbVie in Migraine

AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine to help patients living with this debilitating disease.

At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments and reduce the impact of migraine on their lives.

About AbbVie in Neuroscience

At AbbVie, our commitment to preserve the personhood of those living with neurological and psychiatric disorders is unwavering. Every challenge in this uncharted territory makes us more determined and drives us harder to discover and deliver solutions for patients, care partners and clinicians. AbbVie’s Neuroscience portfolio consists of approved therapies in neurological and psychiatric disorders, including bipolar I disorder, cervical dystonia, major depressive disorder, migraine, Parkinson’s disease, post-stroke spasticity, schizophrenia and others along with a robust pipeline.

We have a strong investment in neuroscience research, with our Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience Discovery site in Ludwigshafen, Germany, where our research and resilience in these challenging therapeutic areas is yielding a deeper understanding of the pathophysiology of neurological and psychiatric disorders, and identifying targets for potential disease-modifying therapeutics aimed at making a difference in people’s lives.

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.


Posted: April 2023

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Qulipta (atogepant) FDA Approval History

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