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FDA Approval New Drug

QULIPTA Approved by the FDA for Preventitive Treatment of Migraine

The U.S. Food and Drug Administration (FDA) approved QULIPTA™ (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 disease.

The approval is supported by data from a robust clinical program evaluating the efficacy, safety, and tolerability of QULIPTA in nearly 2,000 patients who experienced 4 to 14 migraine days per month.

“This approval reflects a broader shift in the treatment and management paradigm for the migraine community. QULIPTA provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients,” said Peter J. Goadsby, M.D., Ph.D., D.Sc., neurologist and professor at University of California, Los Angeles, and King’s College, London, who earned the prestigious Brain Prize in 2021 for his revolutionary research about CGRP’s role in migraine attacks and co-authored the ADVANCE study.

“I’m particularly encouraged by the convenience of the oral daily use of QULIPTA, its rapid onset of significant efficacy, and its safety and tolerability as well as its high patient response rates. This is a milestone in preventive migraine treatment that I hope will help many patients for years to come,” Goadsby said.

 

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