AbbVie’s preventative migraine treatment atogepant (Qulipta™) shows promise

AbbVie has announced that the Phase III PROGRESS trial evaluating atogepant (Qulipta™ in the United States) – an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the preventative treatment of chronic migraine in adults – met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo.

The trial consisted of three groups, taking 60mg atogepant doses once daily (QD), 30mg atogepant twice daily (BID) or placebos across a 12-week treatment period.

The study also demonstrated that treatment with atogepant 60mg QD and 30mg BID resulted in statistically significant improvements in all secondary endpoints after adjustment for multiple comparisons.

The Phase III, global, randomised, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety and tolerability of oral atogepant for the preventative treatment of the debilitating neurological disease, chronic migraine. A total of 778 patients with at least a one-year history of chronic migraine were randomised into one of the three treatment groups.

Efficacy was analysed using two slightly different definitions of the patient population, based on regulatory agency feedback in the US and European Union (EU). 

However, across the 12-week treatment period both the US-focused population patients and the EU-focused population showed improved results. In the US-focused arm, atogepant 60mg QD and 30mg BID treatment arms of the study experienced a decrease of 6.88 and 7.46 monthly migraine days, respectively, compared to patients in the placebo arm, who experienced a decrease of 5.05 monthly migraine days.  Based on the EU-focused population, patients in the 60mg QD and 30mg BID of atogepant treatment arms of the study experienced a decrease of 6.75 and 7.33 monthly migraine days, respectively, compared to patients in the placebo arm, who experienced a decrease of 5.09 monthly migraine days.

The study demonstrated that treatment with atogepant 60mg QD and 30mg BID resulted in statistically significant improvements in all secondary endpoints for both efficacy analysis populations. 

A key secondary endpoint measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period.

The overall safety profile of the PROGRESS study was consistent with safety findings observed in previous studies in an episodic migraine population.

“AbbVie has nearly 12 years of experience in treating chronic migraine, a debilitating disease. We know that no two migraine patients are alike, so it is important for health care providers to have a variety of treatment options,” stated Dr Michael Severino, vice chairman and president, AbbVie. “These data and pending regulatory submissions solidify our commitment to our leading migraine portfolio to help the more than one billion people worldwide living with the migraine. We look forward to taking the next steps to potentially expand the use of atogepant in the United States to include the preventive treatment of chronic migraine in adults, and to working with regulatory agencies globally on additional submissions.”

These data build on the Phase III ADVANCE study results, which evaluated atogepant for the preventative treatment of episodic migraine. The primary endpoint of the ADVANCE study was a statistically significant reduction in mean monthly migraine days across the 12-week treatment period compared to placebo.

Based on the results of PROGRESS trial in chronic migraine, AbbVie intends to submit a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) for the expanded use of atogepant to include the preventative treatment of chronic migraine.

Additionally, study results from the PROGRESS trial, along with the ADVANCE trial data, in episodic migraine, will form the basis for future regulatory submissions globally.