- AbbVie Inc ABBV announced data from its Phase 3 ELEVATE study, evaluating atogepant for the preventive treatment of episodic migraine in people who had previously failed two to four classes of oral preventive medications.
- The ELEVATE study met all primary and secondary endpoints. It demonstrated a statistically significant reduction in monthly migraine days (MMDs) for those with episodic migraine taking atogepant 60 mg QD compared to placebo.
- The primary endpoint was the change from baseline in mean MMDs across 12 weeks. The secondary endpoints included achievement of more than 50% reduction in MMDs, change from baseline in MMDs, and change from baseline in acute medication use days across 12 weeks.
- The study results demonstrated that patients in the atogepant 60 mg once daily (QD) arm experienced a decrease of 4.20 days in their MMDs across the 12-week treatment period, greater than the 1.85-day reduction observed in the placebo arm.
- Atogepant 60 mg QD was well tolerated.
- The most commonly reported treatment-emergent adverse events (atogepant vs. placebo, respectively) included constipation (10.3% vs. 2.5%), COVID-19 (8.3% vs. 9.6%), nausea (7.1% vs. 3.2%), and nasopharyngitis (5.1% vs. 7.6%).
- The FDA recently approved Qulipta as the first and only oral calcitonin gene-related peptide receptor antagonist proven to prevent both episodic and chronic migraine in adults in the U.S.
- Price Action: ABBV shares are down 0.33% at $161.21 during the premarket session on the last check Friday.
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