AbbVie Inc. on Thursday said a Phase 3 study of its migraine drug Qulipta hit its key goals in the preventive treatment of chronic migraine in adults.
The North Chicago, Ill., biopharmaceutical company said Qulipta met the primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo in doses of 60 milligrams once a day and 30 milligrams twice daily across the 12-week treatment period.
AbbVie said the study also showed statistically significant improvements in all secondary endpoints, with an overall safety profile for Qulipta consistent with findings in previous studies.
AbbVie said the study data will support a planned filing for expanded U.S. Food and Drug Administration approval for Qulipta for the preventive treatment of chronic migraine, along with other regulatory submissions around the world.
The FDA last year approved Qulipta for the preventive treatment of episodic migraine in adults.
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