AbbVie Submits Marketing Authorization Application to EMA for Atogepant for the Preventive Treatment of Migraine
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AbbVie (NYSE: ABBV) right now introduced it has submitted a advertising authorization utility (MAA) to the European Medicines Agency (EMA) for atogepant for the prophylaxis of migraine in grownup sufferers who’ve a minimum of 4 migraine days monthly. The utility is supported by the pivotal Phase 3 ADVANCE and PROGRESS research evaluating the security, efficacy, and tolerability of atogepant in grownup sufferers with episodic migraine and persistent migraine, respectively.[i],[ii]  

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Migraine is a fancy neurological illness and one of many main causes of incapacity worldwide.[iii] It is extremely prevalent, affecting greater than 1 billion individuals worldwide,3 together with an estimated 11.4 p.c of the inhabitants in Europe.[iv] If authorised, atogepant can be the primary each day oral CGRP receptor antagonist for the prophylaxis of migraine for grownup sufferers in Europe.

“Far too many people around the world are impacted from the debilitating challenges of migraine, which places a significant social and work-life burden for patients and care partners,” mentioned Michael Gold, M.D., therapeutic space head, neuroscience growth, AbbVie. “At AbbVie, we are committed to advancing science to provide patients impacted by migraine with effective treatment options. If approved, atogepant will provide a prophylactic treatment option for adult migraine patients suffering for more than four days a month.”

The pivotal, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial evaluated the efficacy, security, and tolerability of as soon as each day (QD) oral atogepant for the prophylaxis of episodic migraine. The examine met its major endpoint of a statistically important discount in imply month-to-month migraine days throughout the 12-week therapy interval in comparison with placebo. This was discovered throughout all lively therapy arms of atogepant – 10 mg, 30 mg, and 60 mg QD doses. The grownup sufferers enrolled met the International Classification of Headache Disorders (ICHD) standards for a prognosis of migraine with or with out aura. The examine additionally discovered {that a} higher proportion of atogepant-treated individuals achieved a minimum of a 50% discount in imply month-to-month migraine days for all doses in comparison with placebo and met different key secondary endpoints.

The pivotal, Phase 3, world, randomized, double-blind, placebo-controlled, parallel-group PROGRESS examine, evaluating the security, efficacy, and tolerability of oral atogepant in grownup sufferers for the prophylaxis of persistent migraine, met its major endpoint of statistically important discount from baseline in imply month-to-month migraine days in comparison with placebo throughout the 12-week therapy interval. The trial additionally demonstrated that therapy with atogepant 60 mg as soon as each day (QD) and 30 mg each day (BID), resulted in statistically important enhancements in all secondary endpoints. This features a key secondary endpoint that measured the proportion of sufferers that achieved a minimum of a 50 p.c discount in imply month-to-month migraine days throughout the 12-week therapy interval.

In each, the Phase 3 PROGRESS and Phase 3 ADVANCE research, all doses have been nicely tolerated, and the general security profiles have been in line with security findings noticed in earlier research for the prophylaxis of episodic migraine and persistent migraine populations. The commonest opposed occasions have been constipation and nausea.

The atogepant MAA can be reviewed by the Committee for Medicinal Products for Human Use, which is able to subject an opinion that can be legitimate for all member states of the European Union, in addition to Iceland, Lichtenstein, Northern Ireland and Norway.

About Atogepant

Atogepant is an orally administered, CGRP receptor antagonist (gepant) particularly developed for the prophylaxis therapy of migraine. CGRP and its receptors are expressed in areas of the nervous system related to migraine pathophysiology. Studies have proven that CGRP ranges are elevated throughout migraine assaults and selective CGRP receptor antagonists confer scientific profit in migraine.

About the Phase 3 ADVANCE Clinical Trial1

The pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was designed to guage the efficacy, security, and tolerability of oral atogepant for the prevention of migraine in these with 4 to 14 migraine days monthly. A complete of 910 sufferers have been randomized to one in every of 4 therapy teams evaluating 10 mg, 30 mg, or 60 mg of atogepant as soon as each day, or placebo. Efficacy analyses have been based mostly on the modified intent-to-treat (mITT) inhabitants of 873 sufferers. 

The major endpoint was change from baseline in imply month-to-month migraine days throughout the 12-week therapy interval. All atogepant dose teams met the first endpoint and demonstrated statistically considerably higher decreases in imply month-to-month migraine days in comparison with placebo. Patients handled within the 10 mg/30 mg/60 mg atogepant arms skilled a lower of three.69/3.86/4.2 days, respectively, all in comparison with sufferers within the placebo arm, who skilled a lower of two.48 days (all dose teams vs. placebo, p=<.0001).

A key secondary endpoint measured the proportion of sufferers that achieved a minimum of a 50% discount in imply month-to-month migraine days throughout the 12-week therapy interval. The trial demonstrated that 55.6%/58.7%/60.8% of sufferers within the 10 mg/30 mg/60 mg atogepant arms, respectively, achieved a minimum of a 50% discount, in comparison with 29.0% of sufferers within the placebo arm (all dose teams vs. placebo, p=<.0001).

Additional secondary endpoints measured throughout the 12-week therapy interval included change from baseline in imply month-to-month headache days, imply month-to-month acute-medication use days, and imply month-to-month efficiency of each day actions and bodily impairment area scores of the Activity Impairment in Migraine-Diary (AIM-D), and alter from baseline within the Migraine-Specific Quality of Life Questionnaire (MSQ) Role Function-Restrictive area rating at week 12. The trial demonstrated that therapy with 30 mg and 60 mg doses resulted in statistically important enhancements in all secondary endpoints, whereas therapy with the ten mg dose resulted in statistically important enhancements in 4 out of the six secondary endpoints.

No new security dangers have been noticed in comparison with the security profile noticed within the earlier trial evaluating atogepant. Serious opposed occasions occurred in 0.9% of sufferers handled within the atogepant 10 mg arm and 0.9% of sufferers within the placebo arm. No sufferers within the atogepant 30 mg or 60 mg therapy arms skilled a severe opposed occasion. The commonest opposed occasions reported with a frequency ≥ 5% in a minimum of one atogepant therapy arm, and higher than placebo, have been constipation (7.7%, 7.0% and 6.9% within the 10 mg/30 mg/60 mg atogepant arms, respectively vs. 0.5% for placebo), nausea (5.0%, 4.4% and 6.1% within the 10 mg/30 mg/60 mg atogepant arms, respectively vs. 1.8% for placebo), and higher respiratory tract an infection (4.1%, 5.7% and three.9% within the 10 mg/30 mg/60 mg atogepant arms, respectively vs. 4.5% for placebo). The majority of instances of constipation, nausea and higher respiratory tract an infection have been gentle or average in severity and didn’t result in discontinuation. There have been no hepatic questions of safety recognized on this trial.

About the Phase 3 PROGRESS Clinical Trial2

The Phase 3 PROGRESS scientific trial evaluated the security, tolerability and efficacy of oral atogepant for the prophylaxis therapy of persistent migraine. The affected person inhabitants for the examine included sufferers with a prognosis of persistent migraine for a minimum of one yr, and ≥ to fifteen headache days with eight migraine days within the 28 days previous to randomization. The major endpoint measured the discount from baseline in imply month-to-month migraine days in comparison with placebo, for each doses, together with 60 mg as soon as each day (QD) and 30 mg twice each day (BID), throughout a 12-week therapy interval. The total security profile of the Phase 3 PROGRESS examine was in line with security findings noticed in earlier research in an episodic migraine inhabitants.

Key secondary endpoints for all areas included: Change from baseline in imply month-to-month headache days throughout the 12-week of therapy interval​ (baseline is outlined because the variety of migraine days over the last 28 days previous to the randomization date); Change from baseline in imply month-to-month acute remedy use days throughout the 12-week therapy interval​ (baseline is outlined because the variety of migraine days over the last 28 days previous to the randomization date); Proportion of individuals with a minimum of a 50% discount in imply month-to-month migraine days throughout the 12-week therapy interval​; and alter from baseline in MSQ v2.1 Role Function-Restrictive area rating at Week 12. The MSQ v2.1 is a questionnaire designed to measure health-related high quality of life impairments attributed to migraine up to now 4 weeks. It is split into three domains, assessing how a affected person’s each day, social, and work actions are restricted by migraine; how migraine prevents these actions; and assesses the emotional perform associated with migraine.

For a full itemizing of secondary endpoints throughout all areas, please go to www.clinicaltrials.gov (NCT03855137).

About AbbVie in Neuroscience

At AbbVie, our dedication to preserving personhood for these residing with neurological and psychiatric issues is unwavering. Every problem on this uncharted territory drives us to find and ship options for sufferers, care companions and clinicians. AbbVie’s Neuroscience portfolio consists of authorised therapies and a strong pipeline in neurological and psychiatric issues, together with Alzheimer’s illness, bipolar dysfunction and melancholy, cervical dystonia, main depressive dysfunction, migraine, Parkinson’s illness, spinal twine accidents, post-stroke spasticity, schizophrenia, stroke and others.

We have a powerful funding in neuroscience analysis to assist us higher perceive the pathophysiology of neurological and psychiatric issues and determine targets for potential disease-modifying therapeutics aimed toward making a distinction in individuals’s lives. For extra info, go to www.abbvie.com.

About AbbVie

AbbVie’s mission is to find and ship progressive medicines that resolve severe well being points right now and tackle the medical challenges of tomorrow. We attempt to have a exceptional affect on individuals’s lives throughout a number of key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, girls’s well being and gastroenterology, along with services throughout its Allergan Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.com.

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Forward-Looking Statements

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