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AbbVie (NYSE: ABBV) these days introduced it has submitted a internet marketing authorization software (MAA) to the European Medications Company (EMA) for atogepant for the prophylaxis of migraine in grownup clients who have at the very least 4 migraine days for every month. The software is supported by the pivotal Stage 3 Advance and Development scientific tests assessing the security, efficacy, and tolerability of atogepant in grownup individuals with episodic migraine and chronic migraine, respectively.[i],[ii]
Picture Credit score: fizkes/Shutterstock.com
Migraine is a complex neurological disorder and one particular of the foremost results in of disability all over the world.[iii] It is extremely common, influencing a lot more than 1 billion people today throughout the world,3 together with an approximated 11.4 % of the populace in Europe.[iv] If approved, atogepant would be the initial each day oral CGRP receptor antagonist for the prophylaxis of migraine for grownup sufferers in Europe.
“Far as well lots of persons about the entire world are impacted from the debilitating issues of migraine, which destinations a considerable social and do the job-lifestyle stress for sufferers and care partners,” said Michael Gold, M.D., therapeutic region head, neuroscience progress, AbbVie. “At AbbVie, we are fully commited to advancing science to give individuals impacted by migraine with efficient procedure choices. If accredited, atogepant will give a prophylactic treatment method solution for adult migraine patients suffering for much more than four days a thirty day period.”
The pivotal, Section 3, multicenter, randomized, double-blind, placebo-controlled, parallel-team Progress demo evaluated the efficacy, security, and tolerability of at the time day by day (QD) oral atogepant for the prophylaxis of episodic migraine. The analyze satisfied its main endpoint of a statistically major reduction in mean every month migraine days throughout the 12-week cure interval compared to placebo. This was discovered across all lively therapy arms of atogepant – 10 mg, 30 mg, and 60 mg QD doses. The adult patients enrolled achieved the Worldwide Classification of Headache Issues (ICHD) conditions for a prognosis of migraine with or with no aura. The research also identified that a higher proportion of atogepant-handled contributors obtained at least a 50% reduction in necessarily mean regular monthly migraine times for all doses compared to placebo and met other critical secondary endpoints.
The pivotal, Phase 3, world, randomized, double-blind, placebo-controlled, parallel-team Progress examine, evaluating the basic safety, efficacy, and tolerability of oral atogepant in adult individuals for the prophylaxis of serious migraine, satisfied its key endpoint of statistically significant reduction from baseline in indicate regular migraine times in contrast to placebo across the 12-week cure interval. The trial also shown that treatment with atogepant 60 mg at the time day-to-day (QD) and 30 mg every day (BID), resulted in statistically sizeable enhancements in all secondary endpoints. This contains a important secondary endpoint that calculated the proportion of sufferers that realized at least a 50 % reduction in signify regular migraine times throughout the 12-week treatment time period.
In each, the Phase 3 Development and Stage 3 Progress scientific studies, all doses have been effectively tolerated, and the general security profiles ended up steady with safety findings noticed in prior scientific tests for the prophylaxis of episodic migraine and continual migraine populations. The most frequent adverse occasions were being constipation and nausea.
The atogepant MAA will be reviewed by the Committee for Medicinal Products and solutions for Human Use, which will issue an impression that will be valid for all member states of the European Union, as properly as Iceland, Lichtenstein, Northern Eire and Norway.
About Atogepant
Atogepant is an orally administered, CGRP receptor antagonist (gepant) exclusively made for the prophylaxis therapy of migraine. CGRP and its receptors are expressed in regions of the nervous procedure related with migraine pathophysiology. Studies have proven that CGRP stages are elevated through migraine attacks and selective CGRP receptor antagonists confer medical gain in migraine.
About the Stage 3 Advance Medical Demo1
The pivotal Period 3, multicenter, randomized, double-blind, placebo-managed, parallel-team trial was built to examine the efficacy, protection, and tolerability of oral atogepant for the prevention of migraine in those people with 4 to 14 migraine days for every thirty day period. A overall of 910 people had been randomized to a single of four cure groups analyzing 10 mg, 30 mg, or 60 mg of atogepant the moment each day, or placebo. Efficacy analyses ended up primarily based on the modified intent-to-take care of (mITT) populace of 873 patients.
The main endpoint was improve from baseline in mean month to month migraine days throughout the 12-week therapy interval. All atogepant dose teams satisfied the most important endpoint and demonstrated statistically noticeably increased decreases in mean regular migraine times in contrast to placebo. Patients handled in the 10 mg/30 mg/60 mg atogepant arms seasoned a lower of 3.69/3.86/4.2 days, respectively, all in comparison to individuals in the placebo arm, who professional a reduce of 2.48 days (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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