Lawrence Severt, MD, PhD

"We’ve already got Botox [onabotulinumtoxinA], but we would like to add another option for people with chronic migraine. We’re also thinking about other populations that might benefit, which is why this is a global program for atogepant.”

In March, AbbVie announced that the FDA had accepted its new drug application (NDA) for its investigational agent atogepant (Allergan) for the preventive treatment of migraine in adults with episodic migraine. Its NDA was supported by a clinical program that included the phase 3 ADVANCE study (NCT02848326), the pivotal phase 2b/3 study (NCT0284832) and the phase 3 long-term safety study (NCT03777059).

2021 American Academy of Neurology (AAN) Annual Meeting

, April 17-22, the company released additional data further expanding on the efficacy and safety of atogepant in the ADVANCE study. Lawrence Severt, MD, PhD, director, AbbVie, claims the company is still anticipating a regulatory decision to come within the third quarter of this year, and at the latest by the end of 2021.

Severt, who served as an investigator on ADVANCE, also mentioned that the company has an ongoing study evaluating atogepant in patients with chronic migraine. He sat down with 

to provide background on the regulatory status of atogepant and its illustrious data profile.

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The director at AbbVie discussed the timeline for when a regulatory decision may come for migraine treatment atogepant, and whether additional trials are necessary. 

Regulatory Outlook for Atogepant in Migraine: Lawrence Severt, MD, PhD

"The safety and tolerability profile in the package we submitted for FDA approval was robust and impressive. Dr. [Jessica] Ailani talked about the adverse events. We saw very few safety issues. We saw constipation about 7% [of the time] and a slightly lower rate of nausea, both of which were overwhelmingly mild.” 

In March, AbbVie announced that its orally administered calcitonin gene-related peptide atogepant had its new drug application accepted by the FDA for the preventive treatment of migraine in adults with episodic migraine. With a regulatory decision expected to come in the third quarter of 2021, the drug aims to join a landscape that features the recent approval of fremanezumab (Ajovy; Teva Pharmaceuticals) which earned green light in September 2018.

, April 17-22, atogepant continued to prove its efficacy and safety in a number of abstracts stemming from the phase 3 ADVANCE study. Lawrence Severt, MD, PhD, was among the authors of the study and claims that there are a multitude of advantages atogepant brings to the table, including the oral administration, which is a priority for some patients.

about the growth of the CGRP treatment market and the mechanistic benefits they bring as well as harps on the advantages atogepant could bring to the landscape pending continued regulatory success.

US FDA Accepts AbbVie’s new drug application for atogepant for the preventive treatment of migraine. News release. AbbVie. March 30, 2021. Accessed March 30, 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

The director at AbbVie highlighted where atogepant stands among the increasing treatment landscape of anti-calcitonin gene-related peptide options within the migraine treatment landscape. 

Advantages of Atogepant in Ever-Growing CGRP Market: 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.”

, 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 (

 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.

 To better understand the results presented at AAN 2021, 

sat down with Lawrence Severt, MD, PhD, who was an investigator on the ADVANCE trial and currently serves as a director for AbbVie.

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. 

The director at AbbVie discussed a number of abstracts presented at AAN 2021 involving atogepant and its phase 3 ADVANCE study. 

Lawrence Severt, MD, PhD

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Regulatory Outlook for Atogepant in Migraine: Lawrence Severt, MD, PhD

Advantages of Atogepant in Ever-Growing CGRP Market: Lawrence Severt, MD, PhD

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

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