Positive phase 3 data for atogepant in migraine prevention

▴ AbbVie Company photo
AbbVie announced that the Phase 3 ADVANCE trial evaluating the investigational medicine atogepant in migraine prevention

AbbVie announced that the Phase 3 ADVANCE trial evaluating the investigational medicine atogepant, an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) met its primary endpoint of statistically significantly greater reduction in mean monthly migraine days, compared to placebo, for all doses across the 12-week treatment period. With these results, combined with the prior positive Phase 2/3 trial, AbbVie plans to move forward with regulatory submissions in the United States and other countries. Full data results will be presented at an upcoming medical congress and/or published in a peer-reviewed journal.

“Migraine attacks can be debilitating, but migraine is a treatable disease, and people living with it are not alone in their battle to control it,” said Thomas J. Hudson, M.D., senior vice president of R&D and chief scientific officer, AbbVie. “With the results from these trials, we aim to provide a safe and effective preventive treatment that offers patients and healthcare providers a simple, once daily oral treatment that works specifically by blocking CGRP receptors and preventing migraine.”

The pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the efficacy, safety, and tolerability of oral atogepant for the prevention of migraine in those with 4 to 14 migraine days per month. A total of 910 patients were randomized to one of four treatment groups evaluating 10 mg, 30 mg, or 60 mg of atogepant once daily, or placebo. Efficacy analyses were based on the modified intent-to-treat (mITT) population of 873 patients.

The primary endpoint changed from baseline in mean monthly migraine days across the 12-week treatment period. All atogepant dose groups met the primary endpoint and demonstrated statistically significantly greater decreases in mean monthly migraine days compared to placebo. Patients treated in the 10 mg/30 mg/60 mg atogepant arms experienced a decrease of 3.69/3.86/4.2 days, respectively, all compared to patients in the placebo arm, who experienced a decrease of 2.48 days (all dose groups vs. placebo, p=<.0001).

Migraine is a complex, chronic disease with episodic attacks that are often incapacitating and characterized by headache pain as well as neurologic and autonomic symptoms. It is highly prevalent, affecting more than one billion people worldwide, and is the highest cause of disability worldwide for people under 50 years of age. Due to the unpredictability and fluctuation of attack frequency and severity, migraine has a substantial impact on many aspects of an individual’s life both during and between attacks. Daily activities, work, school, and personal relationships are negatively affected, leading to a significant burden on the person with migraine, their family, and friends, and often extending to employers and healthcare systems.

Tags : #MigraineTreatment #ThomasJHudson #UnitedStates #Abbvie

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

NRAI cautions restaurants about the dangers of aggregator payment gateways and deep discounting on diningDecember 09, 2024
Hot Cocoa: A Surprising Ally in Fighting Stress and Boosting Heart HealthDecember 09, 2024
What Your Headache Says About Your Health And Why It Can Be More Than Just a Temporary PainDecember 09, 2024
Hot Cocoa: A Surprising Ally in Fighting Stress and Boosting Heart HealthDecember 09, 2024
Is Your Favorite Snack a Secret Weapon Against Diabetes?December 07, 2024
Is the Fountain of Youth Hidden in Your Cells? Discover the Future of Ageing With Indian AIDecember 07, 2024
Does Your Heart Have a Mind of Its Own? Science Says Yes!December 07, 2024
Does Your Heart Have a Mind of Its Own? Science Says Yes!December 07, 2024
Heart Risks Are Shrinking Men’s Brains: What Science Reveals About Gender and AgingDecember 06, 2024
P&G India Celebrates 20 Years of P&G Shiksha with its largest ever Employee Volunteer Day Initiative across all offices and sitesDecember 06, 2024
Air India SATS Scales up Green Initiative with AeroWash Now Serving Two of India's Busiest AirportsDecember 06, 2024
The Silent Culprit Behind Osteoarthritis: Are Ultra-Processed Foods Eating Away our BonesDecember 06, 2024
From Daily Pills to 2 Shots Per Year: The Future of HIV ProtectionDecember 06, 2024
BREAKTHROUGH CLINICAL STUDY, FIRST OF ITS KIND, PROVES TRAYA CUSTOMIZED REGIMEN DELIVERS 3X* BETTER RESULTS THAN THE MOST PRESCRIBED HAIR GROWTH SERUM December 06, 2024
The Airborne Mutation: Is Bird Flu Becoming a Human Threat? December 05, 2024
Aster CMI Hospital collaborate with Government of Arunachal Pradesh Provide Affordable Liver Transplantation Services.December 05, 2024
Women missing out on treatment for their number one killerDecember 05, 2024
Packaged Water Under Fire: What FSSAI’s ‘High-Risk’ Tag Means for YouDecember 05, 2024
Life or Death: A New Breakthrough in Detecting Sepsis Before It’s Too LateDecember 05, 2024
Marble Centre International Unveils 'A Shared Memory' at Designuru 4.5December 05, 2024