AbbVie has received the US Food and Drug Administration (FDA) approval, expanding the indication of Qulipta (atogepant 60mg) for the preventive treatment of chronic migraine in adults.

Qulipta is an oral calcitonin gene-related peptide (CGRP) receptor antagonist, specifically developed for the preventive treatment of migraine.

CGRP and its receptors, associated with migraine pathophysiology, are expressed in the regions of the nervous system, and their levels are shown to be elevated during migraine attacks.

The drug was previously approved in the US as a preventive treatment for episodic migraine in adults and the current approval expands its indication to include chronic migraine.

With the expanded approval, Qulipta becomes the first and only FDA-approved oral CGRP receptor antagonist for preventing both episodic and chronic migraine.

AbbVie chief medical officer and senior vice president Roopal Thakkar said: “Since September 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.

“This approval makes AbbVie the only company with three treatments across the spectrum of migraine, including Qulipta as a preventive treatment for both episodic and chronic migraine; BOTOX (onabotulinumtoxinA), our foundational, first FDA-approved preventive treatment for chronic migraine; and UBRELVY (ubrogepant), an acute treatment for migraine attacks.”

The expanded approval is based on the Phase 3 PROGRESS clinical trial, which evaluated the safety, tolerability, and efficacy of oral Qulipta 60mg in adult patients with chronic migraine.

The study met its primary endpoint of the statistically significant reduction in mean monthly migraine days from baseline compared to placebo, along with key secondary endpoints.

The treatment with Qulipta resulted in statistically significant improvements in all six secondary endpoints, with only 19.3 average monthly migraine days (MMDs) for patients.

Qulipta showed an overall safety profile consistent with the episodic migraine patient population and with the most common adverse events including constipation, nausea and fatigue.

In a separate development, AbbVie has secured the European Commission (EC) approval for Rinvoq (upadacitinib) to treat a type of active Crohn’s disease in adults.

Rinvoq is an oral Janus Kinase (JAK) inhibitor indicated for adults who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

It is the seventh approved indication for Rinvoq in the European Union (EU), following rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, non-radiographic axial spondyloarthritis (ankylosing spondylitis, atopic dermatitis, and ulcerative colitis.

AbbVie chief scientific officer, research and development senior vice president Thomas Hudson said: “The EC approval of Rinvoq in Crohn’s disease is a significant milestone in offering patients the first and only once-daily oral treatment that can provide endoscopic improvement, and sustained symptom relief, making a difference in their daily lives.

“With existing therapies, not all patients are able to achieve adequate disease control to meet their treatment goals, which is why we continue to embrace the challenge of expanding our IBD portfolio with new treatment options.”