The Food and Drug Administration approved Ubrelvy, the company’s ubrogepant treatment, on Monday. The oral medication is aimed at treating migraines in patients who are unresponsive to common migraine treatments, such as triptans, or are at risk of cardiovascular disorders. Allergan, which anticipated a December approval by the FDA, said Ubrelvy will be available for sale in the U.S. in the first quarter.
The U.S. Food and Drug Administration today approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Ubrelvy is not indicated for the preventive treatment of migraine. It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.