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AbbVie Gets EU Nod for Aquipta as Acute Treatment for Migraine
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Key Takeaways
ABBV secured EU approval for Aquipta for acute migraine treatment in adults with or without aura.
Aquipta already has EU approval as a once-daily preventive migraine treatment in adults.
Phase III ECLIPSE data showed significant pain freedom at two hours, sustained through 48 hours.
AbbVie (ABBV - Free Report) announced that the European Commission has approved Aquipta (atogepant) for the acute treatment of migraine in adults with or without aura, to be taken as needed.
This marks the second approved indication for Aquipta in migraine in the European Union. The drug is already approved in the EU as a once-daily CGRP receptor antagonist (gepant) for the prevention of migraine in adults with at least four migraine days per month.
The latest approval in the EU was based on data from the pivotal phase III ECLIPSE study, which evaluated the safety, efficacy and tolerability of Aquipta versus placebo for the acute treatment of migraine.
Data from the study showed that treatment with Aquipta led to statistically significant pain freedom compared with placebo at two hours following the first migraine attack. The treatment effect was sustained through 48 hours and remained clinically meaningful and consistent across multiple migraine attacks.
AbbVie markets atogepant under the trade name Qulipta in the United States and several other countries across the world.
ABBV’s Price Performance
Year to date, shares of AbbVie have lost 4.2% against the industry’s increase of 1.7%.
Image Source: Zacks Investment Research
ABBV’s Neuroscience Franchise Aids Growth
AbbVie’s neuroscience portfolio is making a meaningful contribution to the company’s top-line growth. Revenues from its neuroscience portfolio increased 26% year over year to $2.88 billion in the first quarter of 2026.
The strong performance was driven by continued momentum for the depression drug Vraylar, migraine medicines Ubrelvy and Qulipta, Botox Therapeutic and Parkinson’s disease (PD) therapy Vyalev.
Importantly, AbbVie’s migraine portfolio maintained strong momentum in the first quarter. Ubrelvy sales rose 41% year over year to $339 million, while Qulipta generated $296 million in revenues, up 51%. Per management, Ubrelvy and Qulipta/Aquipta represent a combined $3 billion-plus peak sales opportunity. However, competition in the target market remains a concern.
Competition for ABBV in the Targeted Space
Qulipta/Aquipta faces competition from established CGRP-targeting therapies in the migraine market, including Teva Pharmaceutical’s (TEVA - Free Report) Ajovy, Eli Lilly’s (LLY - Free Report) Emgality and Pfizer’s (PFE - Free Report) Nurtec ODT/Vydura.
While TEVA’s Ajovy and LLY’s Emgality are widely used preventive migraine treatments, PFE’s Nurtec ODT/Vydura is approved for both acute and preventive use in migraine in certain markets, potentially increasing competitive pressure.
Aquipta is also likely to face competition from other marketed migraine treatments as well as emerging therapies currently in development.
View the Zacks #1 Rank List
Image: Bigstock
AbbVie Gets EU Nod for Aquipta as Acute Treatment for Migraine
Key Takeaways
AbbVie (ABBV - Free Report) announced that the European Commission has approved Aquipta (atogepant) for the acute treatment of migraine in adults with or without aura, to be taken as needed.
This marks the second approved indication for Aquipta in migraine in the European Union. The drug is already approved in the EU as a once-daily CGRP receptor antagonist (gepant) for the prevention of migraine in adults with at least four migraine days per month.
The latest approval in the EU was based on data from the pivotal phase III ECLIPSE study, which evaluated the safety, efficacy and tolerability of Aquipta versus placebo for the acute treatment of migraine.
Data from the study showed that treatment with Aquipta led to statistically significant pain freedom compared with placebo at two hours following the first migraine attack. The treatment effect was sustained through 48 hours and remained clinically meaningful and consistent across multiple migraine attacks.
AbbVie markets atogepant under the trade name Qulipta in the United States and several other countries across the world.
ABBV’s Price Performance
Year to date, shares of AbbVie have lost 4.2% against the industry’s increase of 1.7%.
Image Source: Zacks Investment Research
ABBV’s Neuroscience Franchise Aids Growth
AbbVie’s neuroscience portfolio is making a meaningful contribution to the company’s top-line growth. Revenues from its neuroscience portfolio increased 26% year over year to $2.88 billion in the first quarter of 2026.
The strong performance was driven by continued momentum for the depression drug Vraylar, migraine medicines Ubrelvy and Qulipta, Botox Therapeutic and Parkinson’s disease (PD) therapy Vyalev.
Importantly, AbbVie’s migraine portfolio maintained strong momentum in the first quarter. Ubrelvy sales rose 41% year over year to $339 million, while Qulipta generated $296 million in revenues, up 51%. Per management, Ubrelvy and Qulipta/Aquipta represent a combined $3 billion-plus peak sales opportunity. However, competition in the target market remains a concern.
Competition for ABBV in the Targeted Space
Qulipta/Aquipta faces competition from established CGRP-targeting therapies in the migraine market, including Teva Pharmaceutical’s (TEVA - Free Report) Ajovy, Eli Lilly’s (LLY - Free Report) Emgality and Pfizer’s (PFE - Free Report) Nurtec ODT/Vydura.
While TEVA’s Ajovy and LLY’s Emgality are widely used preventive migraine treatments, PFE’s Nurtec ODT/Vydura is approved for both acute and preventive use in migraine in certain markets, potentially increasing competitive pressure.
Aquipta is also likely to face competition from other marketed migraine treatments as well as emerging therapies currently in development.
ABBV’s Zacks Rank
AbbVie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.