AbbVie has announced results from its phase 3 PROGRESS trial evaluating Qulipta (atogepant) – a treatment for adult patients suffering from chronic migraines – which has shown that a once-daily 60mg dose as well as a twice-daily 30mg dose of Qulipta works in preventing chronic migraine. It significantly reduced the number of migraines experienced by the target group of patients compared to those receiving the placebo.
The phase 3 PROGRESS trial is a global, randomised, double-blind, placebo-controlled, parallel-group study evaluated the safety, effectiveness and tolerability of Qulipta for preventing chronic migraines. The trial took place over a 12-week period.
For patients diagnosed with chronic migraines, the impact can be debilitating, with patients experiencing headaches on 15 or more days per month for more than three months, which on at least eight days per month has features of migraine headache.
The trial involved 778 patients with at least a one-year history of chronic migraine and were randomised into one of three treatment groups. The results demonstrated that patients treated with Qulipta – once-daily dose of 60mg and a 30mg dose twice-daily – experienced statistically significant improvements in all secondary endpoints for effectiveness.
The data builds on the previous positive phase 3 ADVANCE trial results, which assessed Qulipta as a treatment for the prevention of episodic migraine. Qulipta was approved in the US for episodic migraine in September 2021.
Following the positive results of the PROGRESS trial, AbbVie plans to submit a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the expanded use of Qulipta to include the preventive treatment of chronic migraine.
The combined study results from the phase 3 PROGRESS trial, coupled with the phase 3 ADVANCE trial data, will form the basis for future regulatory submissions internationally. Presently, the use of Qulipta as a preventive treatment of chronic migraine in the US is not approved and its safety and effectiveness have not yet been evaluated by regulatory authorities.
“We know that no two migraine patients are alike, so it is important for healthcare providers to have a variety of treatment options,” said Michael Severino, vice chairman and president at AbbVie.
He added: “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.”