AbbVie prepares to seek additional approval for migraine treatment

Photo courtesy of AbbVie Inc.

AbbVie‘s Qulipta (atogepant) has reached a new clinical milestone in the treatment of migraine headaches. This morning, the Illinois-based company announced Qulipta hit the mark in its Phase III PROGRESS study by reducing the average number of monthly migraine days compared to placebo.

Qulipta, a Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist, Has Gained US Approval Food and Drug Administration (FDA) last year as a preventive treatment for episodic migraines. With data from the Phase III PROGRESS study, AbbVie intends to seek regulatory approval for Qulipta for the expanded use of atogepant to include the preventative treatment of chronic migraine. The condition is defined as a headache on 15 or more days per month for more than three months, with at least eight days per month exhibiting the characteristics of a migraine.

The data showed that Qulipta achieved its primary objective of a statistically significant reduction in the average number of monthly migraine days with a dose of 60 mg once daily, as well as with doses of 30 mg twice daily for a period 12 week treatment. Study data showed that patients who received 60 mg once daily or 30 mg twice daily saw a decrease of 6.88 and 7.46 migraine days per month, respectively, compared to patients who received a placebo. These patients experienced a decrease of 5.05 migraine days per month, AbbVie reported.

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

Michael Severino, president and vice president of AbbVie, touted the company’s experience in treating chronic migraines.

“We know that no two migraine patients are alike, so it’s important that healthcare providers have a variety of treatment options. This data and pending regulatory submissions reinforce our commitment to our leading migraine portfolio to help the more than one billion people worldwide living with 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 preventative treatment of chronic migraine in adults, and to working with regulatory agencies around the world on additional submissions.”

In addition to Qulipta, AbbVie’s migraine portfolio is bolstered by its crown jewel of Botox, a widely used injectable first approved for the treatment of migraine in 2010, as well as Ubrelvy (ubrogepant)that the company has earned in its Acquisition of $63 billion from 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 headaches and other associated indications, which may also include vomiting, nausea, phonophobia, which is a fear of loud noises, and/or photophobia, sensitivity in the light. It is estimated that approximately 12-14% of all people, or more than one billion worldwide, are affected by migraines. In the United States, approximately 29 million people are affected. Migraines are the leading cause of disability worldwide for people under the age of 50.

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

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

About Antoine L. Cassell

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