In August, AbbVie has secured European Commission (EC) approval for AQUIPTA® (atogepant) as a preventive treatment for adults experiencing four or more migraine days per month, making it the European Union’s first and only daily oral CGRP receptor antagonist treatment for both chronic and episodic migraines.

Dr. Michael Seminerio, Therapeutic Area Lead and Senior Global Medical Affairs Director for AbbVie’s migraine portfolio, agreed to explain a bit more about this approval and provide some background context for the clinical data, safety and the impact this news can have on the migrane sufferes in the European Union. 

Michael is a pharmaceutical leader with specific expertise in matters related to drug development and data generation, evidenced by years of experience working in clinical research and the pharmaceutical industry. Michael’s career began as a clinical pharmacologist at the University of Chicago, IL, where he conducted clinical research, and designed Phase 1 clinical trials for the advanced solid tumor clinic. As his career progressed, Michael began to learn more about the complexities of migraine and pain and decided to transition his expertise to the world of neuroscience.

Before starting at AbbVie, Michael held several positions at Teva Pharmaceuticals, ultimately leading the US neuroscience medical affairs team, where he was responsible for all US medical affairs activities within neuroscience.

Andrii: Michael, what sets AQUIPTA® apart from other migraine prophylaxis treatments currently available in the EU? Can you briefly describe the mechanism of action of AQUIPTA® and its significance in migraine management?

Michael: AbbVie is a committed leader in migraine with an extensive history of migraine research, and we’re proud we can bring AQUIPTA (atogeapnt) to migraine sufferers in Europe as it is the first and only once daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) in the EU for the prophylaxis of migraine in adults who have four or more migraine days per month. It has proven to significantly reduce mean monthly migraine days in adults with episodic and chronic migraine, which allows migraine patients – including those who have had an insufficient response to prior preventative migraine treatments – the potential to experience more days of migraine freedom.

AQUIPTA also provides adults suffering from migraine in the EU with a simple, once-daily oral treatment option specifically developed to prevent migraine attacks and interfere with CGRP receptors, which are believed to be involved in migraine.

AQUIPTA is part of a class of medicines called gepants, which act as calcitonin gene-related peptide (CGRP) receptor antagonists. CGRP is a protein (neuropeptide) that is released around the brain. When CGRP is released, it can cause inflammation, and for most migraine patients, results in the pain associated with a migraine attack. AQUIPTA works by blocking the CGRP protein from attaching to receptors to prevent migraine attacks.

Andrii: There are an estimated 41 million people in Europe suffering from migraines. With AQUIPTA® now being the first and only once-daily oral CGRP receptor antagonist in the EU for both chronic and episodic migraines, what do you see as the primary benefits for patients?

Michael: Far too many people around the world are impacted by migraine, a complex neurological disease and one of the leading causes of disability worldwide, which is why AbbVie continues to advance our science to provide effective treatment options for people living with this debilitating condition.

Data from two pivotal Phase 3 trials, ADVANCE and PROGRESS, demonstrate that AQUIPTA reduces the impact of migraine on patients’ lives through significant reductions in migraine / headache days and improved function and quality of life across the 12-week treatment periods compared to placebo, and provides a once daily tablet that is well-tolerated with few side effects.

Andrii: The PROGRESS and ADVANCE clinical studies showed statistically significant results. Can you provide more insight into the key takeaways from these studies? How do the results from these studies compare to similar treatments in terms of efficacy and safety?

Michael: The PROGRESS and ADVANCE studies evaluated 60 mg once-daily (QD) AQUIPTA in adult patients with chronic migraine and episodic migraine, respectively. Both studies met their primary endpoint of a statistically significant reduction in mean monthly migraine days, compared to placebo across the 12-week treatment period. In the PROGRESS study, the changes from baseline in mean monthly migraine days was a reduction of 6.8 days for AQUIPTA 60 mg QD and a reduction of 5.1 days for placebo (p=0.0024). In the ADVANCE study, the changes from baseline in mean monthly migraine days was a reduction of 4.1 days for AQUIPTA 60 mg QD and a reduction of 2.5 days for placebo (p≤0.001).

Statistically significant improvements were also seen in all secondary endpoints for PROGRESS and ADVANCE, with both studies measuring the proportion of patients that achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. The PROGRESS study demonstrated that 40% of patients treated with AQUIPTA 60 mg QD achieved at least a 50% reduction in mean monthly migraine days, compared to 27% of patients in the placebo arm (p=0.0024), while the ADVANCE study demonstrated that 59% of patients treated with AQUIPTA 60 mg QD achieved at least a 50% reduction in mean monthly migraine days, compared to 29% of patients in the placebo arm (p≤0.0001).

Other notable data includes the ELEVATE study, which evaluated atogepant for the preventive treatment of episodic migraine among patients who previously failed 2-4 classes of conventional oral medications for migraine prevention. The results demonstrated that adult patients in the atogepant 60 mg QD arm experienced a decrease of 4.20 days in their mean monthly migraine days across the 12-week treatment period, which was statistically significantly greater than the 1.85 day reduction observed in the placebo.

Andrii: Can you shed some light on the adverse events noted in the studies, especially nausea and constipation, and how they were managed?

Michael: Safety was evaluated in 2,657 patients with migraine who received at least one dose of atogepant in clinical studies. Of these, 1,225 patients were exposed to atogepant for at least 6 months and

826 patients were exposed for 12 months. In both studies, AQUIPTA 60 mg QD was well tolerated and the most common adverse events were constipation (8%), nausea (9%) and fatigue (5%). Most of the events were mild to moderate in severity and do not lead to study discontinuation.

In the ADVANCE Study, constipation was reported in 6.9% of patients treated with AQUITPA 60 mg QD compared to 0.5% for placebo, and nausea was reported in 6.1% of patients treated with AQUITPA 60 mg QD compared to 1.8% for placebo. In the PROGRESS Study, constipation was reported in 10% of patients treated with AQUITPA 60 mg QD compared to 3% for placebo, and nausea was reported in 10% treated with AQUITPA 60 mg QD compared to 4% for placebo.

Andrii: How does AQUIPTA®’s approval in Europe fit into AbbVie’s broader global strategy for addressing migraines? Given that atogepant is also approved in the US and Canada under the name QULIPTA®, can we expect to see any global collaborations or initiatives to raise awareness or improve access?

Michael: At AbbVie, we believe that people living with migraine should have access to medications to treat this debilitating disease. Our current migraine portfolio and treatments demonstrate our commitment and dedication to addressing the unmet needs of people living with migraine – and we continue to strive for science that makes a difference. AbbVie is the only pharmaceutical company to offer three treatments across the frequencies of migraine, including acute, episodic, and chronic migraine.

Andrii: AbbVie has been involved in neuroscience for over three decades. Can you tell us about the company’s approach to innovation in this space? Are there other promising treatments in AbbVie’s pipeline that we should keep an eye out for?

Michael: The resilience of people living with or impacted by neurological disorders is what motivates us at AbbVie to advance research in neuroscience and we are committed to preserving personhood for those living with neurological and psychiatric disorders.

We work across all stages of neuroscience development in search of novel therapies that have the potential to treat chronic disabling neurological conditions such as Parkinson’s disease, migraine, stroke, Alzheimer’s disease, cervical dystonia and other neurological and psychiatric disorders.

For example, AbbVie is working closely with regulatory authorities around the world regarding approvals for ABBV-951, a potential new treatment option to address unmet needs in the treatment of advanced Parkinson disease. ABBV-951 is a device aided-therapy that delivers foslevodopa/foscarbidopa, a soluble formulation of levodopa/carbidopa prodrugs, through continuous subcutaneous infusion. ABBV-951 has received approval in the EU for the drug component; however, the pump has not yet been fully evaluated. ABBV-951 drug and pump have both been approved in Japan and are currently under review in other countries.

Our drug development is grounded in partnership – from patients, to patient organizations and clinicians, we ensure their individual experiences, perspectives and needs are part of the clinical development process at AbbVie.

Andrii: What message would you like to convey to healthcare professionals and migraine sufferers regarding this recent approval and AbbVie’s commitment to improving lives?

Michael: Individuals experiencing frequent disabling migraine attacks shouldn’t have to just settle with living with migraine. The approval of AQUIPTA represents a meaningful advancement for the migraine community in Europe, providing adults with four or more migraine days per month a new prophylactic treatment option that offers the possibility of sustained migraine prevention.

With more than three decades of experience in neuroscience, AbbVie is committed to providing meaningful treatment options today and advancing innovation for the future. Our portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders, and psychiatric disorders, along with a robust pipeline of transformative therapies.

Topics: Novel Therapeutics   

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• Source: https://www.biopharmatrend.com/post/707-interview-with-michael-seminerio/