Friday, AbbVie Inc (NYSE:ABBV) released an interim analysis of an ongoing, open-label, 156-week Phase 3 extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with chronic or episodic migraine.
According to Benzinga Pro data, shares are trading lower with a session volume of 3.9 million compared to the average volume of 5.6 million.
Also read: AbbVie raises long-term outlook for new immunology drugs even as fourth-quarter sales and profit fall.
The extension study included participants who enrolled in and completed the Phase 3 PROGRESS and ELEVATE clinical trials with a monthly migraine day burden of 14.5 days.
Key findings from the interim analysis include:
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Monthly migraine days improved by an average of 8.5 days in weeks 13-16 and this remained consistent over 48 weeks.
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Similar improvements were observed for monthly headache days and monthly acute medication days.
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70% of subjects achieved a ≥50% reduction in monthly migraine days at weeks 13–16, and this remained consistent throughout 48 weeks of open-label treatment.
The 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 United States and Aquipta in the European Union (EU), is approved in 45 countries.
In 2023, Qulipta had sales of $408 million, and in the fourth quarter of 2023, sales were $114 million.
AbbVie has raised its long-term forecast for Ubrelvy and Qulipta sales and expects combined peak sales of Ubrelvy and Qulipta to be more than $3 billion, an increase of about $1 billion compared to previous forecasts for peak sales of more than $1 billion for each asset.
Continue reading: Biden administration is sending drug companies opening offers for the Medicare program’s first-ever drug pricing negotiations.
Price promotion: ABBV shares were down 2.75% at $162.92 at last check on Friday.
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This article: What will happen to AbbVie shares on Friday? originally appeared on Benzinga.com
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