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

Donna B. Jones

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AbbVie (NYSE: ABBV) currently announced it has submitted a marketing and advertising authorization application (MAA) to the European Medications Agency (EMA) for atogepant for the prophylaxis of migraine in grownup patients who have at the very least 4 migraine days for each month. The application is supported by the pivotal Section 3 Advance and Progress reports analyzing the safety, efficacy, and tolerability of atogepant in grownup people with episodic migraine and persistent migraine, respectively.[i],[ii]  

Migraine

Image Credit rating: fizkes/Shutterstock.com

Migraine is a complicated neurological condition and just one of the major leads to of disability around the world.[iii] It is hugely common, affecting a lot more than 1 billion folks around the globe,3 like an believed 11.4 per cent of the inhabitants in Europe.[iv] If permitted, atogepant would be the initial everyday oral CGRP receptor antagonist for the prophylaxis of migraine for adult patients in Europe.

“Far also numerous individuals all around the environment are impacted from the debilitating problems of migraine, which places a considerable social and work-existence stress for people and treatment companions,” said Michael Gold, M.D., therapeutic location head, neuroscience progress, AbbVie. “At AbbVie, we are fully commited to advancing science to deliver people impacted by migraine with efficient treatment method choices. If accepted, atogepant will offer a prophylactic therapy alternative for grownup migraine individuals suffering for much more than four times a month.”

The pivotal, Section 3, multicenter, randomized, double-blind, placebo-controlled, parallel-team Progress trial evaluated the efficacy, protection, and tolerability of when day by day (QD) oral atogepant for the prophylaxis of episodic migraine. The review fulfilled its key endpoint of a statistically substantial reduction in necessarily mean every month migraine times across the 12-week remedy interval compared to placebo. This was located throughout all active remedy arms of atogepant – 10 mg, 30 mg, and 60 mg QD doses. The grownup clients enrolled met the Global Classification of Headache Ailments (ICHD) requirements for a diagnosis of migraine with or with out aura. The examine also discovered that a larger proportion of atogepant-treated participants accomplished at the very least a 50% reduction in mean month-to-month migraine times for all doses as opposed to placebo and fulfilled other critical secondary endpoints.

The pivotal, Stage 3, world-wide, randomized, double-blind, placebo-managed, parallel-group Development review, assessing the safety, efficacy, and tolerability of oral atogepant in grownup clients for the prophylaxis of chronic migraine, achieved its primary endpoint of statistically considerable reduction from baseline in necessarily mean monthly migraine times in contrast to placebo across the 12-7 days procedure time period. The demo also demonstrated that procedure with atogepant 60 mg when everyday (QD) and 30 mg each day (BID), resulted in statistically significant advancements in all secondary endpoints. This incorporates a vital secondary endpoint that calculated the proportion of sufferers that reached at the very least a 50 percent reduction in suggest every month migraine times throughout the 12-7 days procedure period.

In both equally, the Section 3 Progress and Period 3 Advance research, all doses have been nicely tolerated, and the in general protection profiles had been constant with protection results noticed in past scientific studies for the prophylaxis of episodic migraine and chronic migraine populations. The most common adverse functions have been constipation and nausea.

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

About Atogepant

Atogepant is an orally administered, CGRP receptor antagonist (gepant) specifically developed for the prophylaxis treatment method of migraine. CGRP and its receptors are expressed in areas of the anxious process linked with migraine pathophysiology. Scientific studies have demonstrated that CGRP levels are elevated in the course of migraine attacks and selective CGRP receptor antagonists confer medical gain in migraine.

About the Section 3 Progress Medical Demo1

The pivotal Stage 3, multicenter, randomized, double-blind, placebo-managed, parallel-team trial was developed to consider the efficacy, security, and tolerability of oral atogepant for the prevention of migraine in individuals with 4 to 14 migraine times for every month. A full of 910 people were randomized to one of 4 procedure teams evaluating 10 mg, 30 mg, or 60 mg of atogepant as soon as daily, or placebo. Efficacy analyses were based on the modified intent-to-take care of (mITT) inhabitants of 873 individuals. 

The major endpoint was transform from baseline in necessarily mean regular monthly migraine days across the 12-7 days treatment method period. All atogepant dose groups satisfied the key endpoint and shown statistically appreciably higher decreases in signify regular migraine days as opposed to placebo. Individuals handled in the 10 mg/30 mg/60 mg atogepant arms skilled a lower of 3.69/3.86/4.2 days, respectively, all as opposed to people in the placebo arm, who experienced a lower of 2.48 days (all dose teams 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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