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.
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Posted-In: Briefs MigrainesBiotech News Health Care FDA General
