Submission is based on pivotal Phase 3 PROGRESS chronic migraine study evaluating atogepant (QULIPTATM) in adult patients that met primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo
– If approved, atogepant (QULIPTA) would be the first gepant (oral calcitonin gene-related peptide [CGRP] receptor antagonist) with a broad preventive treatment of migraine indication that expands treatment to patients with chronic migraine
– Label expansion would make AbbVie the only company to offer two preventive treatments for those with chronic migraine, atogepant (QULIPTA) and onabotulinumtoxinA (BOTOX®)
AbbVie (NYSE: ABBV) today announced that it has submitted a supplemental New Drug Application (sNDA) for atogepant (QULIPTATM) to the U.S. Food and Drug Administration (FDA) to support the preventive treatment of chronic migraine in adults. If approved, atogepant (QULIPTA) would be the first gepant (oral calcitonin gene-related peptide [CGRP] receptor antagonist) approved for the broad indication of the preventive treatment of migraine, including episodic and chronic. The sNDA submission includes data from the pivotal Phase 3 PROGRESS trial in patients with chronic migraine, which supplements the existing data in episodic migraine. People living with chronic migraine experience headaches for 15 or more days per month, which, on at least eight of those days per month, have the features of migraine.1
“Having one oral medication to treat both episodic and chronic migraine would be an important advancement for health care providers and patients,” said Michael Gold, M.D., therapeutic area head, neuroscience development, AbbVie. “This sNDA approval would also diversify AbbVie’s migraine portfolio and make it the only company to offer two approved preventive treatments for those living with chronic migraine. No two migraine patients are alike, so having multiple treatment options with unique mechanisms of action is critical.”
The pivotal Phase 3 PROGRESS trial met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period in adults with chronic migraine. The trial also demonstrated that treatment with atogepant 60 mg once daily (QD) and 30 mg daily (BID) resulted in statistically significant improvements in all six secondary endpoints. This includes a key secondary endpoint 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.
The overall safety profile of the Phase 3 PROGRESS study was consistent with safety findings observed in previous studies in an episodic migraine population. The most common adverse events were constipation and nausea.
Atogepant is marketed as QULIPTATM in the United States and is FDA-approved to treat adults with episodic migraine. Use of atogepant for the preventive treatment of chronic migraine in the United States is not approved, and its safety and efficacy have not been evaluated by regulatory authorities.
About QULIPTA™ (atogepant)
QULIPTA™ was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of episodic migraine in adults in September 2021. It is available in the United States as the first and only gepant (oral calcitonin gene-related peptide [CGRP] receptor antagonist) developed specifically for the preventive treatment of migraine and is now under review by the FDA to expand the episodic indication to also treat patients with chronic migraine. 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 – 10 mg, 30 mg and 60 mg.
About BOTOX® (onabotulinumtoxinA)
BOTOX® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Today, BOTOX® is FDA-approved for 12 therapeutic indications, including chronic migraine, overactive bladder, leakage of urine (incontinence) due to overactive bladder caused by a neurologic condition in adults and in pediatric patients five years of age and older, cervical dystonia, adult and pediatric spasticity, and severe underarm sweating (axillary hyperhidrosis).
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.1 It is highly prevalent, affecting more than 1 billion people worldwide, including 39 million people in the United States alone, and is the highest cause of disability worldwide for people under 50 years of age.3-5
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.1 Chronic migraine impacts 1%-2% of the global population.6 It is differentiated from episodic migraine by its more debilitating disease profile including greater prevalence of comorbid conditions as well as higher frequency of headache and migraine days.7-9 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.10-14 Significant direct and indirect costs are also associated with chronic migraine, leading to economic burden for patients and healthcare systems.15-17
About AbbVie in Migraine
At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables health care 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.
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, women’s health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio.