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AbbVie (ABBV) Files Qulipta sNDA for Chronic Migraine Prevention

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AbbVie (ABBV - Free Report) submitted a supplemental new drug application (sNDA) with the FDA, seeking approval for the expanded use of its newly approved CGRP receptor antagonist, Qulipta (atogepant), for the prevention of chronic migraine.

Qulipta was approved for the preventive treatment of episodic migraine in adults in September last year. With the latest approval for chronic migraine prevention, Qulipta becomes the only CGRP receptor antagonist approved for the broad preventive treatment of migraine indication.

AbbVie’s stock has risen 5.9% this year so far against a decrease of 2.6% for the industry.

 

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The sNDA for the chronic migraine prevention indication was based on data from the pivotal phase III PROGRESS study, which met its primary endpoint of a statistically significant reduction from baseline in mean monthly migraine days, compared to placebo, for all doses evaluated across a 12-week treatment period. In addition, the PROGRESS study showed that both doses (60 mg once daily and 30 mg twice daily) of Qulipta resulted in statistically significant improvements in all six secondary endpoints.

Qulipta generated sales of $11 million in the first quarter of 2022. AbbVie now offers two preventive medicines for chronic migraine, Qulipta and its blockbuster medicine, Botox. Botox is approved for both therapeutic as well as cosmetic use. AbbVie’s other oral CGRP medicine, Ubrelvy, is approved for the treatment of acute migraine.

The migraine market is heavily crowded with several anti-CGRP drugs available like Amgen’s (AMGN - Free Report) Aimovig, Lilly’s Emgality and Teva’s (TEVA - Free Report) Ajovy.

Teva’s Ajovy is a subcutaneous injection approved for the preventive treatment of migraine. Ajovy recorded total sales of $72 million in the first quarter of 2022 and Teva expects the drug to generate approximately $400 million in revenues in 2022.

Amgen’s Aimovig is a subcutaneous injection, also approved as a preventive treatment of migraine. Amgen generated revenues of $101 million from Aimovig in the first quarter, up 53% year over year.

A key competitor to Quilipta is Biohaven Pharmaceutical’s (BHVN - Free Report) oral CGRP antagonist, Nurtec ODT, which is approved for the preventive treatment of episodic migraine as well as a treatment of acute migraine.

In the first quarter of 2022, Biohaven Pharmaceuticals generated $123.6 million in sales from Nurtec, up 182% year over year. Biohaven is also evaluating Nurtec in a phase II study in patients with trigeminal neuralgia, a chronic pain condition.

Zacks Rank and Stocks to Consider

AbbVie currently has a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.