Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • The Pharma 50

AbbVie shares positive Phase 3 atogepant data to prevent chronic migraine

By Brian Buntz | March 10, 2022

AbbVieGepants have gained ground in recent years as a migraine treatment following the FDA’s approval of Allergan’s Ubrelvy (ubrogepant) in 2019.

Now, AbbVie (NYSE:ABBV) has announced that a Phase 3 study testing Qulipta (atogepant) met its primary endpoint of reducing mean monthly migraine days over placebo.

FDA approved atogepant as a preventive treatment of episodic migraine in adults on September 28, 2021.

The company hopes the data will convince FDA to authorize the expanded use of atogepant as a preventive treatment of chronic migraine.

AbbVie plans on filing a supplemental New Drug Application (sNDA) with the agency.

In the Phase 3 PROGRESS study, both the 60-mg once-daily and 30-mg twice daily versions of the oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) met the endpoint over a 12-week treatment period.

In the study, 778 participants shared eDiary headache data. One treatment arm received the 60-mg once-daily ubrogepant, another the 30-mg twice-daily version, while the remaining third received placebo.

[Related: A neurologist dishes on the migraine treatment landscape]

Qulipta bottle

Qulipta bottle image courtesy of AbbVie

Patients getting the 60 version had a reduction of 6.88 average monthly migraine days, while those receiving the 30-mg version had a 7.46 reduction. Placebo recipients had a decrease in 5.05 monthly migraine days.

Recipients of atogepant also showed improvements in all secondary endpoints.

AbbVie also noted that the safety profile of the Progress study was in line with that of other studies.

“AbbVie has nearly 12 years of experience in treating chronic migraine, a debilitating disease. We know that no two migraine patients are alike, so it is important for health care providers to have a variety of treatment options,” said Dr. Michael Severino, vice chairman and president, AbbVie, in a news release.

Severino said the company plans on filing regulatory submissions to bolster its migraine portfolio.

AbbVie’s previous Phase 3 Advance study tested atogepant as a preventive episodic migraine treatment.


Filed Under: clinical trials, Drug Discovery, Neurological Disease
Tagged With: AbbVie, atogepant, gepants, migraine, Qulipta
 

Tell Us What You Think! Cancel reply

You must be logged in to post a comment.

Related Articles Read More >

Aduhelm
Nine out of ten U.S. neurologists have Aduhelm efficacy doubts
Athira Pharma
​​Athira Pharma to continue open-label Alzheimer’s extension studies
Biogen
Biogen CEO Michel Vounatsos to step aside as Aduhelm sales continue to sputter
Janssen
Why Janssen’s nipocalimab could represent a ‘pipeline in a pathway’

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • The Pharma 50