Benzinga | Sep 29, 2021 08:37AM EDT

FDA Gives Nod To First Oral CGRP Receptor To Prevent Migraine From AbbVie

* The FDA has approved AbbVie Inc's (NYSE:ABBV) Qulipta (atogepant) to prevent episodic migraines in adults.

* Qulipta is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for the preventive treatment of migraine.

* Qulipta will be available from early October in three strengths -- 10 mg, 30 mg, and 60 mg.

* The approval is supported by data from a clinical program in nearly 2,000 patients who experienced 4 to 14 migraine days per month.

* All Qulipta dose groups demonstrated statistically significant reductions in mean monthly migraine days compared to placebo.

* Patients treated with 60 mg of Qulipta across 12 weeks experienced a 4.2-day reduction from a baseline of 7.8.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: ABBV stock traded 0.49% higher at $107.87 during the premarket session on the last check Wednesday.