AbbVie Snags New Chronic Migraine Indication for Qulipta

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FDA expanded the indication for AbbVie’s episodic migraine medication Qulipta (atogepant) to include prevention of chronic migraines, making it the first oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent both episodic and chronic migraine.

AbbVie is also presenting Phase 3 trial data on a separate study on Qulipta as a preventive treatment of episodic migraine in people who had previously failed two to four classes of oral preventive medications on Tuesday, April 25, at the 2023 American Academy of Neurology (AAN) Annual Meeting in Boston.

Since it was approved in the fall of 2021, Qulipta has “helped people living with episodic migraine prevent migraine attacks, reducing the daily burden of migraine. Now, those with the most challenging to treat chronic migraine can also rely on Qulipta to significantly reduce their migraine days," said Roopal Thakkar, senior vice president and chief medical officer of AbbVie.

Qulipta produced $158 milion in net revenues in the U.S. last year as preventive medication against episodic migraine.

Qulipta’s wholesale acquisition cost is $1,040.55 for a 30-day supply. AbbVie said that its patient support program, called Qulipta Complete, means that eligible commercially insured patients may pay as little as $0 per month. Also, the company says that if patients experience issues with insurance coverage, AbbVie offers additional support options to help eligible patients access Qulipta.

With the expanded indications, AbbVie sports three treatments across the spectrum of migraine, including Qulipta, Botox (onabotulinumtoxinA), and Ubrelvy (ubrogepant), an acute treatment for migraine attacks, according to Thakkar.

Qulipta's expanded chronic migraine indication is based on the pivotal Phase 3 PROGRESS trial evaluating Qulipta 60 mg once daily in adult patients with chronic migraine, which met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period.

“The PROGRESS trial also demonstrated that treatment with Qulipta resulted in statistically significant improvements in all of its six secondary endpoints,” said Aubrey Adams, Ph.D., U.S. area head for Therapeutic Neurotoxins & Migraine, Medical Affairs at AbbVie. "This includes key secondary endpoints that measured the proportion of patients that achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period and improvements in function and reduction in activity impairment due to migraine.”

The efficacy results are consistent with those in the ADVANCE episodic migraine trial, according to AbbVie.

"The FDA approval is an important milestone, providing those most impacted by migraine with a new, safe and effective treatment option in a convenient, once-daily pill," said Peter McAllister, M.D., Director of the New England Center for Neurology and Headache. "Qulipta's data demonstrate that it helps reduce the burden of migraine by delivering improvements in function, with high response rates and sustained efficacy over 12 weeks. These are critical factors neurologists and headache specialists consider when prescribing a treatment option, particularly for those with chronic migraine.”

Qulipta blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of Qulipta is indicated for the preventive treatment of chronic migraine.

The overall safety profile of Qulipta is consistent with the episodic migraine patient population, with the most common adverse events including constipation, nausea and fatigue/sleepiness.