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AbbVie's (ABBV) Migraine Prevention Drug Qulipta Gets FDA Nod

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AbbVie Inc. (ABBV - Free Report) announced that the FDA has approved its oral CGRP receptor antagonist Qulipta (atogepant) as a preventive treatment of episodic migraine in adults. The drug is now the first and only CGRP receptor antagonist for the given indication. Qulipta will be available in the United States from early next month.

The latest FDA nod was based on data from a robust clinical program that included results from the phase III ADVANCE study, a pivotal phase IIb/III study and the phase III long-term safety study. These studies were conducted on patients having four to 14 migraine days per month.

Data from the pivotal phase III study showed that treatment with Qulipta (across all doses groups) led to a statistically significant and rapid and meaningful reductions in mean monthly migraine days versus placebo over a treatment period of 12 days.

Data from the phase III ADVANCE study was published in the New England Journal of Medicine in August, which showed that through the 12 weeks of treatment, participants treated with Qulipta experienced a significant reduction in migraine and headache days.

Majority of the patients treated with Qulipta experienced a 50-100% reduction in monthly migraine days across 12 weeks – a key secondary endpoint in the ADVANCE study.

Shares of AbbVie have inched up 0.2% so far this year compared with the industry’s growth of 8.2%.

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We note that AbbVie already has an oral CGRP, Ubrelvy, approved for the treatment of acute migraine. The drug generated sales worth $207 million in the first six months of 2021 and has witnessed strong uptake since its launch in 2020. AbbVie’s Botox is also approved to prevent headaches in adults with chronic migraine.

With the FDA approving Qulipta, AbbVie has now become the only company to offer three products across the full spectrum of migraine treatment, including preventive therapies for chronic and episodic migraine, as well as acute treatment for migraine attacks. The approval of Qulipta should strengthen the company’s migraine portfolio in the days ahead.

The migraine market is heavily crowded with several anti-CGRP drugs like Amgen’s (AMGN - Free Report) Aimovig, Lilly’s (LLY - Free Report) Emgality and Teva’s Ajovy, which are already approved by the FDA for the given indication.

Biohaven Pharmaceutical’s (BHVN - Free Report) oral CGRP antagonist, Nurtec ODT, which is also approved for the preventive treatment of migraine as well as a treatment of acute migraine, can be another major competitor for AbbVie’s Ubrelvy and Qulipta.

Zacks Rank

AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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