FDA Approves New Acute Treatment for Migraine With or Without Aura

The US Food and Drug Administration (FDA) approved Ubrelvy (ubrogepant) tablets for the acute treatment of migraine with or without aura in adults.

“Ubrelvy represents an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication. The FDA is pleased to approve a novel treatment for patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies,” said Billy Dunn, MD, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.

Ubrogepant is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine. Ubrogepant is not indicated for preventing migraine.

—Amanda Balbi


FDA approves new treatment for adults with migraine [press release]. Silver Spring, MD: US Food and Drug Administration; December 23, 2019.