February 25, 2024

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AbbVie Submits Marketing Authorization Application to EMA for Atogepant for the Preventive Treatment of Migraine

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AbbVie (NYSE: ABBV) currently declared it has submitted a advertising and marketing authorization application (MAA) to the European Medicines Agency (EMA) for atogepant for the prophylaxis of migraine in adult sufferers who have at minimum four migraine times for every thirty day period. The application is supported by the pivotal Phase 3 Progress and Development studies evaluating the security, efficacy, and tolerability of atogepant in grownup people with episodic migraine and chronic migraine, respectively.[i],[ii]  

Migraine

Graphic Credit score: fizkes/Shutterstock.com

Migraine is a complicated neurological condition and 1 of the main causes of disability around the world.[iii] It is really widespread, affecting much more than 1 billion persons all over the world,3 together with an estimated 11.4 per cent of the populace in Europe.[iv] If authorized, atogepant would be the initial everyday oral CGRP receptor antagonist for the prophylaxis of migraine for grownup clients in Europe.

“Far as well many people close to the environment are impacted from the debilitating troubles of migraine, which places a important social and do the job-daily life burden for patients and treatment associates,” said Michael Gold, M.D., therapeutic area head, neuroscience improvement, AbbVie. “At AbbVie, we are committed to advancing science to offer clients impacted by migraine with productive treatment solutions. If accredited, atogepant will provide a prophylactic remedy selection for grownup migraine individuals struggling for much more than four days a month.”

The pivotal, Period 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group Progress trial evaluated the efficacy, safety, and tolerability of once daily (QD) oral atogepant for the prophylaxis of episodic migraine. The research satisfied its main endpoint of a statistically major reduction in signify month to month migraine times throughout the 12-7 days remedy interval when compared to placebo. This was identified throughout all lively treatment arms of atogepant – 10 mg, 30 mg, and 60 mg QD doses. The grownup sufferers enrolled met the Global Classification of Headache Ailments (ICHD) standards for a diagnosis of migraine with or with out aura. The examine also located that a greater proportion of atogepant-taken care of contributors reached at the very least a 50% reduction in indicate monthly migraine days for all doses in comparison to placebo and satisfied other essential secondary endpoints.

The pivotal, Section 3, world, randomized, double-blind, placebo-managed, parallel-group Development examine, evaluating the security, efficacy, and tolerability of oral atogepant in adult people for the prophylaxis of serious migraine, satisfied its most important endpoint of statistically sizeable reduction from baseline in indicate regular migraine days in comparison to placebo throughout the 12-week cure period of time. The demo also demonstrated that cure with atogepant 60 mg after daily (QD) and 30 mg daily (BID), resulted in statistically considerable advancements in all secondary endpoints. This contains a essential secondary endpoint that measured the proportion of clients that reached at minimum a 50 % reduction in mean regular monthly migraine times throughout the 12-week treatment period.

In both of those, the Period 3 Progress and Stage 3 Progress experiments, all doses have been perfectly tolerated, and the all round basic safety profiles ended up dependable with safety conclusions observed in former research for the prophylaxis of episodic migraine and continual migraine populations. The most prevalent adverse situations have been constipation and nausea.

The atogepant MAA will be reviewed by the Committee for Medicinal Merchandise for Human Use, which will difficulty an feeling that will be valid for all member states of the European Union, as nicely as Iceland, Lichtenstein, Northern Eire and Norway.

About Atogepant

Atogepant is an orally administered, CGRP receptor antagonist (gepant) specially created for the prophylaxis cure of migraine. CGRP and its receptors are expressed in regions of the nervous process affiliated with migraine pathophysiology. Research have demonstrated that CGRP degrees are elevated through migraine assaults and selective CGRP receptor antagonists confer medical gain in migraine.

About the Period 3 Advance Medical Demo1

The pivotal Stage 3, multicenter, randomized, double-blind, placebo-managed, parallel-team trial was built to evaluate the efficacy, protection, and tolerability of oral atogepant for the prevention of migraine in people with 4 to 14 migraine times for each month. A full of 910 patients had been randomized to a single of four cure groups analyzing 10 mg, 30 mg, or 60 mg of atogepant as soon as everyday, or placebo. Efficacy analyses were based on the modified intent-to-treat (mITT) populace of 873 clients. 

The primary endpoint was transform from baseline in mean monthly migraine days across the 12-7 days therapy interval. All atogepant dose groups satisfied the main endpoint and demonstrated statistically substantially larger decreases in indicate every month migraine times in contrast to placebo. Individuals taken care of in the 10 mg/30 mg/60 mg atogepant arms experienced a lower of 3.69/3.86/4.2 times, respectively, all in contrast to patients in the placebo arm, who experienced a decrease of 2.48 times (all dose groups vs. placebo, p=<.0001).

A key secondary endpoint measured the proportion of patients that achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. The trial demonstrated that 55.6%/58.7%/60.8% of patients in the 10 mg/30 mg/60 mg atogepant arms, respectively, achieved at least a 50% reduction, compared to 29.0% of patients in the placebo arm (all dose groups vs. placebo, p=<.0001).

Additional secondary endpoints measured across the 12-week treatment period included change from baseline in mean monthly headache days, mean monthly acute-medication use days, and mean monthly performance of daily activities and physical impairment domain scores of the Activity Impairment in Migraine-Diary (AIM-D), and change from baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role Function-Restrictive domain score at week 12. The trial demonstrated that treatment with 30 mg and 60 mg doses resulted in statistically significant improvements in all secondary endpoints, while treatment with the 10 mg dose resulted in statistically significant improvements in four out of the six secondary endpoints.

No new safety risks were observed compared to the safety profile observed in the previous trial evaluating atogepant. Serious adverse events occurred in 0.9% of patients treated in the atogepant 10 mg arm and 0.9% of patients in the placebo arm. No patients in the atogepant 30 mg or 60 mg treatment arms experienced a serious adverse event. The most common adverse events reported with a frequency ≥ 5% in at least one atogepant treatment arm, and greater than placebo, were constipation (7.7%, 7.0% and 6.9% in the 10 mg/30 mg/60 mg atogepant arms, respectively vs. 0.5% for placebo), nausea (5.0%, 4.4% and 6.1% in the 10 mg/30 mg/60 mg atogepant arms, respectively vs. 1.8% for placebo), and upper respiratory tract infection (4.1%, 5.7% and 3.9% in the 10 mg/30 mg/60 mg atogepant arms, respectively vs. 4.5% for placebo). The majority of cases of constipation, nausea and upper respiratory tract infection were mild or moderate in severity and did not lead to discontinuation. There were no hepatic safety issues identified in this trial.

About the Phase 3 PROGRESS Clinical Trial2

The Phase 3 PROGRESS clinical trial evaluated the safety, tolerability and efficacy of oral atogepant for the prophylaxis treatment of chronic migraine. The patient population for the study included patients with a diagnosis of chronic migraine for at least one year, and ≥ to 15 headache days with eight migraine days in the 28 days prior to randomization. The primary endpoint measured the reduction from baseline in mean monthly migraine days compared to placebo, for both doses, including 60 mg once daily (QD) and 30 mg twice daily (BID), across a 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.

Key secondary endpoints for all regions included: Change from baseline in mean monthly headache days across the 12-week of treatment period​ (baseline is defined as the number of migraine days during the last 28 days prior to the randomization date) Change from baseline in mean monthly acute medication use days across the 12-week treatment period​ (baseline is defined as the number of migraine days during the last 28 days prior to the randomization date) Proportion of participants with at least a 50% reduction in mean monthly migraine days across the 12-week treatment period​ and change from baseline in 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. It is divided into three domains, assessing how a patient’s daily, social, and work activities are limited by migraine how migraine prevents these activities and assesses the emotional function related with migraine.

For a full listing of secondary endpoints across all regions, please go to www.clinicaltrials.gov (NCT03855137).

About AbbVie in Neuroscience

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

We have a strong investment in neuroscience research to help us better understand the pathophysiology of neurological and psychiatric disorders and identify targets for potential disease-modifying therapeutics aimed at making a difference in people’s lives. For more information, visit www.abbvie.com.

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, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.

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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, among others, 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 indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 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 2021 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 to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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