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FDA Approves AbbVie's Qulipta For Preventive Treatment Of Migraine

The U.S. Food and Drug Administration approved AbbVie's (ABBV) Qulipta or atogepant for the preventive treatment of episodic migraine in adults.

Qulipta is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of migraine, the company said in a statement.

The approval is supported by data from a clinical program evaluating the efficacy, safety and tolerability of QULIPTA in nearly 2,000 patients who experienced 4 to 14 migraine days per month, including the pivotal Phase 3 ADVANCE study, the pivotal Phase 2b/3 study, and the Phase 3 long-term safety study.

AbbVie noted that Qulipta demonstrated statistically significant, clinically meaningful rapid and continuous reductions in mean monthly migraine days among adults with episodic migraine compared to placebo across the 12-week treatment period with significant reductions seen in weeks 1-4.

The pivotal trial showed that when taking Qulipta, the majority of patients experienced between a 50-100% reduction in monthly migraine days across 12 week.

Migraine is a complex disease with recurrent attacks that are often incapacitating and characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea. It is highly prevalent, affecting more than 1 billion people worldwide, including 39 million people in the U.S. alone.

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