Health Canada Approves QULIPTA™ (atogepant) for Chronic Migraine Prevention in Adults

MONTRÉAL, May 8, 2024 - Health Canada has recently approved QULIPTA (atogepant) for the prevention of migraines in adults experiencing at least four migraine days per month. QULIPTA stands out as the first and only oral, small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) designed to prevent both episodic and chronic migraine.

Rami Fayed, Vice President and General Manager of AbbVie Canada, highlighted the importance of this approval. "QULIPTA has provided substantial relief to Canadians with episodic migraines since December 2022. Now, it extends its benefits to those suffering from chronic migraines, which are notably difficult to treat," stated Fayed. This approval positions AbbVie uniquely in the pharmaceutical industry, offering three treatments covering the entire spectrum of migraines: QULIPTA for both episodic and chronic prevention, BOTOX® (onabotulinumtoxinA) for chronic migraine prevention, and UBRELVY® (ubrogepant) for acute migraine attacks.

The expanded indication for QULIPTA in chronic migraine is supported by the Phase 3 PROGRESS trial. This pivotal study evaluated the efficacy of QULIPTA 60 mg once daily in adults with chronic migraines and found a significant reduction of -6.9 from baseline in mean monthly migraine days, compared to a reduction of -5.1 for the placebo over a 12-week period. Patients in the trial had an average of 19.2 monthly migraine days at the start.

Dr. Ian Finkelstein, Medical Director of the Toronto Headache & Pain Clinic, emphasized the debilitating nature of chronic migraines. "For many of my patients, chronic migraines make daily activities unbearable and lead to isolation from work, family, and friends," he said. Dr. Finkelstein noted that QULIPTA has already shown efficacy in treating episodic migraines and welcomed its approval for chronic migraine prevention, offering a new treatment option to patients.

QULIPTA is administered as a once-daily oral dose and is available in three strengths (10 mg, 30 mg, and 60 mg) for the prevention of episodic migraines. For chronic migraines, only the 60 mg dose is indicated. The safety profile of QULIPTA remains consistent with that observed in patients with episodic migraines, with common adverse events including nausea, constipation, diarrhea, and fatigue.

Wendy Gerhart, Executive Director of Migraine Canada, remarked on the significance of introducing new migraine-specific medications. "Chronic migraine is a persistent struggle for many. The approval of QULIPTA offers an additional safe and effective option, which we believe will positively impact the migraine community," she said.

Migraine is a complex neurological condition characterized by recurrent attacks lasting between 4 to 72 hours. Symptoms can include moderate to severe pain, nausea, vomiting, sensitivity to light (photophobia), and sound (phonophobia). Approximately 2.7 million Canadians have been diagnosed with migraines, though the actual number of sufferers is likely higher. Migraines are categorized as episodic when there are fewer than 15 headache days per month and chronic when there are 15 or more headache days per month.

QULIPTA (atogepant) is a specifically developed oral, small-molecule CGRP receptor antagonist for preventing both episodic and chronic migraines. It functions by blocking the binding of CGRP to its receptor, which is thought to play a role in migraine pathophysiology.

AbbVie, committed to improving the lives of those with neurological and psychiatric disorders, offers a range of treatments for conditions including migraine, movement disorders, and psychiatric disorders. Their robust research pipeline aims to deliver innovative therapies that address these challenging conditions.

AbbVie continues to strive towards discovering and providing advanced treatments to tackle serious health issues, making a significant impact across various therapeutic areas such as immunology, oncology, neuroscience, and eye care.