The FDA has approved ubrogepant (Ubrelvy; Allergan) for the acute treatment of migraine with or without aura in adults, making it the first-in-class oral calcitonin gene-related peptide (CGRP) antagonist for this indication.1
The new drug application (NDA) was supported by data from the 2 pivotal studies—ACHIEVE I and II—as well as 2 additional safety studies—UBR-MD-04 and 3110-105-002. The study results showed that both doses were effective, with patients reporting significant rates of pain freedom and freedom from most bothersome symptoms at 2 hours post-dose. It is contraindicated for co-administration with strong CYP3A4 inhibitors.
“Migraine is an often-disabling condition that affects an estimated 37 million people in the U.S.,” said Billy Dunn, MD, acting director, Office of Neuroscience, Center for Drug Evaluation and Research, FDA, in a statement. “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,” Dunn added.
ACHIEVE I was a multicenter, double-blind, placebo-controlled study (NCT02828020) that included 1672 patients with migraine, randomly assigned 1:1:1 to either a 50 mg ubrogepant (n = 556), 100 mg ubrogepant (n = 557), or placebo (n = 559). Ultimately, the modified intention-to-treat population included 1436 participants.2,3
Among the 3 dose groups, 19.2% of patients in the 50 mg ubrogepant group (P = .002, adjusted for multiplicity, for comparison with placebo), 21.2% of patients in the 100 mg ubrogepant group (P <.0001) and 11.8% of patients in the placebo group experienced freedom from pain at 2 hours after the initial dose. At 2 hours, 38.6%, 37.7% and 27.8% of patients in the 50 mg, 100 mg, and placebo groups had freedom from the most bothersome symptom respectively.