AbbVie Submits sNDA to FDA for Oral CGRP Receptor Antagonist Qulipta (Atogepant) for Chronic Migraine Prevention

AbbVie Submits sNDA to FDA for Qulipta (Atogepant) to Prevent Migraine Attacks in Adults with Chronic Migraine

Migraine is a complex neurological disease. Patients experience recurrent severe, throbbing headaches, along with symptoms such as extreme sensitivity to light or sound, and vomiting, significantly impacting daily life. It is estimated that over 1 billion people worldwide are affected by migraines. Chronic migraine patients experience headaches on 15 or more days per month, with at least 8 of those days characterized by migraine symptoms.

Qulipta was approved by the U.S. FDA in September 2021 for the preventive treatment of episodic migraine in adults. Qulipta is an oral CGRP receptor antagonist. CGRP and its receptor are expressed in areas of the nervous system associated with the pathophysiology of migraine. Studies have shown that CGRP expression increases during migraine attacks. Qulipta can antagonize CGRP signaling with a once-daily dose.

The Primary Objective of the Phase 3 PROGRESS Clinical Trial was to Evaluate the Efficacy, Safety, and Tolerability of Qulipta as a Preventive Treatment for Chronic Migraine in Adults. The results showed that Qulipta met the primary endpoint of the trial, demonstrating a statistically significant reduction in the average number of migraine days per month compared to baseline versus placebo. The trial also showed that treatment with Qulipta at a dose of 60 mg once daily or 30 mg twice daily resulted in statistically significant improvements across all six secondary endpoints. The overall safety profile of Qulipta in the Phase 3 PROGRESS clinical trial was consistent with what was previously observed in patients with episodic migraine. The most common adverse reactions were constipation and nausea.

"Having an oral medication that can treat both episodic and chronic migraines is a significant advancement for both healthcare providers and patients," said Dr. Michael Gold, head of neuroscience therapy development at AbbVie. "If approved, AbbVie will become the first company to offer two preventive therapies for chronic migraine patients. No two migraine patients are the same, so having multiple treatment options with different mechanisms of action is very important."

References:

[1] AbbVie Submits Supplemental New Drug Application to U.S. FDA for Atogepant (QULIPTA™) to Support Label Expansion for the Preventive Treatment of Migraine. Retrieved June 21, 2022 from https://news.abbvie.com/news/press-releases/abbvie-submits-supplemental-new-drug-application-to-us-fda-for-atogepant-qulipta-to-support-label-expansion-for-preventive-treatment-migraine.htm

Original Title:AbbVie's CGRP Receptor Inhibitor Submitted for Regulatory Approval, Benefiting Various Migraine Patients

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