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

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

"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).

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