FDA approves expanded indication for AbbVie’s chronic migraine treatment

pharmafile | April 18, 2023 | News story | Medical Communications  

US-based AbbVie has announced that the FDA has granted approval for the expanded indication of its preventative chronic migraine treatment Qulipta (atogepant).


Qulipta is an oral calcitonin gene-related peptide (CGRP) receptor antagonist, and the only one approved to prevent migraine across frequencies, including episodic and chronic. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology and studies have shown elevated levels of CGRP during migraine attacks ‒ Qulipta blocks CGRP, preventing the migraine.


Its expansion approval is based on the phase 3 PROGRESS trial, which evaluated Qulipta’s 60mg once-daily dose in adult patients. Study data showed that Qulipta met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days (MMDs) compared to placebo across 12 weeks. The trial also demonstrated statistically significant improvements in all six secondary endpoints, including patients who achieved at least 50% reduction in MMDs and improvements in function and reduction in activity impairment due to migraine.


Peter McAllister MD, director of the New England Center for Neurology and Headache, commented: “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. Qulipta’s data demonstrates 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.”


James Spargo

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