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FDA Alerts

FDA approves atogepant for adults with chronic migraine

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The U.S. Food and Drug Administration (FDA) has approved expanding the indication of atogepant (Qulipta) for the preventive treatment of migraine in adults, according to a press release. This is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine.

Atogepant has received expanded indication for chronic migraine treatment based on the Phase 3 PROGRESS trial, which showed a significant reduction in mean monthly migraine days compared to placebo over 12 weeks. The trial also demonstrated improvements in six secondary endpoints, including function and activity impairment due to migraine. These efficacy results are consistent with those in the ADVANCE episodic migraine trial.

“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, MD, Director of the New England Center for Neurology and Headache in the press release. “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.”

Read the full press release here.

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