Friday, AbbVie Inc (NYSE:ABBV) released an interim analysis of an ongoing Phase 3, open-label 156-week extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with chronic or episodic migraine.
The shares are trading lower with a session volume of 3.9 million versus the average volume of 5.6 million, as per the data from Benzinga Pro.
Also Read: AbbVie Lifts Long-Term Outlook For New Immunology Drugs, Even As Q4 Revenue and Profit Fall.
The extension study included participants who had enrolled in the Phase 3 PROGRESS and ELEVATE clinical trials with a baseline monthly migraine day burden of 14.5 days and completed these studies.
Key findings from the interim analysis include:
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Monthly migraine days improved on average by 8.5 days at Weeks 13-16 and this was consistent over 48 weeks.
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Similar improvements were observed for monthly headache days and monthly acute medication use days.
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70% of subjects achieved ≥50% reduction in monthly migraine days at Weeks 13-16, and this was consistent during the 48 weeks of open-label treatment.
Overall safety results were consistent with the known safety profile of atogepant 60 mg, and no new safety signals were identified.
The most common treatment-emergent adverse events (≥5%) were COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%).
Atogepant, also known as Qulipta in the U.S. and Aquipta in the European Union (EU), is approved in 45 countries.
In 2023, Qulipta generated sales of $408 million, with fourth-quarter 2023 sales of $114 million.
AbbVie raised its long-term outlook for Ubrelvy and Qulipta revenues and expects peak combined Ubrelvy and Qulipta revenues of more than $3 billion, an increase of approximately $1 billion compared to previous guidance for peak revenues of more than $1 billion for each asset.
Price Action: ABBV shares are down 2.75% at $162.92 on the last check Friday.
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This article What’s Going On AbbVie Stock On Friday? originally appeared on Benzinga.com
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Rachel Carter is a health and wellness expert dedicated to helping readers lead healthier lives. With a background in nutrition, she offers evidence-based advice on fitness, nutrition, and mental well-being.
