Atogepant Continues to Shine in Phase 3 ADVANCE Study: Lawrence Severt, MD, PhD

"What was surprising to use was the 50%, 75%, and even 100% reduction rates. That will be very meaningful for patients to hear and understand, as well as for clinicians to communicate.”

At the 2021 American Academy of Neurology (AAN) Annual Meeting, April 17-22, researchers presented results from the pivotal phase 3 ADVANCE trial (NCT02848326), which evaluated the efficacy and safety of atogepant, AbbVie’s orally administered calcitonin gene-related peptide (CGRP) migraine treatment. There were a number of abstracts from the study, which included data on patient-reported outcomes, long-term safety and tolerability, and migraine-specific quality of life measures.

The trial included 910 randomized patients, with more than 87% completing the 12-week treatment period across all groups. All told, the percentage of participants who achieved a greater than 50% reduction in their 3-month average of monthly migraine days (MMDs) for atogepant were 56% for 10 mg, 59% for 30 mg, and 61% for 60 mg compared to 29% on placebo (P <.0001 all doses).¹

In March, AbbVie announced that the FDA accepted its new drug application for atogepant for the preventive treatment of migraine in adults with episodic migraine, with a regulatory decision expected to come in the third quarter of 2021.² To better understand the results presented at AAN 2021, NeurologyLive sat down with Lawrence Severt, MD, PhD, who was an investigator on the ADVANCE trial and currently serves as a director for AbbVie.

For more coverage of AAN 2021, click here.

REFERENCES

1. Ailani J, Lipton R, Goadsby P, et al. Atogepant significantly reduces mean monthly days in the phase 3 trial (ADVANCE) for the preventive treatment of migraine. Presented at 2021 American Academy of Neurology; April 17-22.

2. US FDA Accepts AbbVie’s new drug application for atogepant for the preventive treatment of migraine. News release. AbbVie. March 30, 2021. April 21, 2021. https://news.abbvie.com/news/press-releases/us-fda-accepts-abbvies-new-drug-application-for-atogepant-for-preventive-treatment-migraine.htm#:~:text=NORTH%20CHICAGO%2C%20Ill.%2C%20March,antagonist%20(gepant)%2C%20for%20the