FDA approves Qulipta for prevention of migraine – AbbVie

The FDA has approved Qulipta (atogepant tablets), from AbbVie, for the preventive treatment of episodic migraine in adults. The approval of Qulipta was based on findings from the Phase III ADVANCE study, a Phase II/III efficacy, safety, and tolerability study, and a Phase III long-term safety study.

In the pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial, 910 patients in the indicated population were randomized 1:1:1:1 to receive Qulipta at 10, 30, or 60 mg, or placebo. Number of migraine days at baseline ranged from 7.5 to 7.9 days across the four groups. Changes in the number of migraine days from baseline to 12 weeks for patients receiving 10, 30, or 60 mg were -3.7 days, -3.9 days, and -4.2 days, respectively, compared with -2.5 days for placebo.

Findings also supported a secondary endpoint measuring the proportion of patients who had a 50% or greater reduction in monthly migraine days across the 12-week period. They showed that 56%, 59%, and 61% of patients receiving 10 mg, 30 mg, or 60 mg Qulipta, respectively, achieved a 50%-100% reduction, compared with 29% of placebo patients.

Qulipta is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for the preventive treatment of migraine disease..