AbbVie Prepares to Seek Supplemental Approval for Migraine Treatment

AbbVie’s Migraine treatment awaits approval. (Photo courtesy of AbbVie Inc)

AbbVie’s Qulipta (atogepant) notched another clinical milestone in the migraine treatment. This morning, the Illinois-based company announced Qulipta hit the mark in its Phase III PROGRESS study by reducing mean monthly migraine days compared to placebo.

Qulipta, a calcitonin gene-related peptide (CGRP) receptor antagonist, won approval from the U.S. Food and Drug Administration (FDA) last year as a preventive treatment for episodic migraine headaches. With the data from the Phase III PROGRESS study, AbbVie intends to seek regulatory approval for Qulipta for the expanded use of atogepant to include the preventive treatment of chronic migraines. The condition is defined as experiencing a headache on 15 or more days per month for more than three months, with at least eight of the days per month demonstrating features of a migraine.

Data showed that migraine treatment drug Qulipta met its primary endpoint of statistically significant reduction of mean monthly migraine days with both a once-per-day 60 mg dose, as well as twice-daily doses of 30 mg during a 12-week treatment period. The study data showed that patients who received 60 mg once per day or 30 mg twice daily saw a decrease of 6.88 and 7.46 monthly migraine days, respectively, compared to patients who received a placebo. Those patients experienced a decrease of 5.05 monthly migraine days, AbbVie reported.

The PROGRESS data also demonstrated that treatment with both doses resulted in statistically significant improvements in all secondary endpoints for both efficacy analysis populations. One of the key secondary endpoints included the proportion of patients who achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period.

Michael Severino, president and vice chairman of AbbVie, touted the company’s experience in migraine treatment.

“We know that no two migraine patients are alike, so it is important for health care providers to have a variety of treatment options. 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,” Severino said in a statement. “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.”

In addition to Qulipta, AbbVie’s migraine portfolio is held up by its crown jewel of Botox, a widely-used injectable first approved for migraine treatment in 2010, as well as Ubrelvy (ubrogepant), which the company gained in its $63 billion acquisition of Allergan. Ubrelvy has been approved for the acute (immediate) treatment of migraine with or without aura, which is a sensory phenomenon or visual disturbance.

Migraines are a complicated neurological disorder marked by episodic headache and other associated indications, that can also include vomiting, nausea, phonophobia, which is a fear of loud noises, and/or photophobia, sensitivity to light. It is estimated that approximately 12% to 14% of all people, more than a billion worldwide, are affected by migraines. In the United States, about 29 million people are affected. Migraines are the highest cause of disability worldwide for people under 50 years of age.

For Qulipta, the PROGRESS study builds on the Phase III ADVANCE study results, which supported the migraine treatment drug’s approval for the preventive treatment of episodic migraine. Qulipta achieved its primary and secondary endpoint of demonstrating a statistically significant reduction in mean monthly migraine days across the 12-week treatment period, compared to placebo.

In the PROGRESS trial, Qulipta continued to maintain a consistent safety profile.