AbbVie has announced the interim analysis of an ongoing Phase 3, open-label 156-week extension study that evaluates the long-term safety, tolerability, and efficacy of oral atogepant for preventing migraine. The study included participants with chronic or episodic migraine, and the results showed that the overall long-term safety profile of atogepant was consistent with previous findings, with no new safety concerns identified. The analysis also demonstrated improvements in key efficacy outcomes, including a reduction in monthly acute medication use days.
During the study, monthly migraine days improved by an average of 8.5 days during weeks 13-16, and this improvement was consistent over the 48-week treatment period. Seventy percent of subjects achieved a 50% or greater reduction in monthly migraine days during weeks 13-16, and this response was sustained throughout the treatment period.
The most common treatment-emergent adverse events reported were COVID-19, nasopharyngitis, and constipation.
Sait Ashina, lead author of the study and director of the Comprehensive Headache Center at Beth Israel Deaconess Medical Center, highlighted the significance of these findings for the migraine population. He emphasized that atogepant’s ability to reduce migraine days and acute medication use across the spectrum of the disease is a crucial step in achieving migraine freedom.
Atogepant, also known as QULIPTA® in the U.S. and AQUIPTA® in the European Union, is an approved oral calcitonin gene-related peptide (CGRP) receptor antagonist for both episodic and chronic migraine in adults. AbbVie plans to pursue regulatory submissions for atogepant in additional international markets.
The findings from this analysis will be showcased in an oral presentation at the American Academy of Neurology (AAN) Annual Meeting Scientific Platform Session for Emerging Science.
AbbVie operates in the pharmaceutical industry, specifically in the field of migraine prevention and treatment. Migraine is a prevalent neurological disorder that affects millions of people worldwide, causing recurring moderate to severe headaches accompanied by other symptoms, such as nausea, sensitivity to light and sound, and visual disturbances.
The market for migraine treatments is substantial and continues to grow. According to a report by Grand View Research, the global migraine therapeutics market size was valued at over $2.6 billion in 2020 and is expected to reach $6.7 billion by 2028, with a compound annual growth rate (CAGR) of 11.6% during the forecast period. This growth can be attributed to factors such as the increasing prevalence of migraines, the development of novel therapies, and the rising awareness and diagnosis of the condition.
However, despite the availability of various migraine treatments, there are still unmet needs, especially for individuals who experience chronic or refractory migraines. Many existing treatments have limitations in terms of efficacy, tolerability, and long-term safety.
Atogepant, marketed as QULIPTA® in the U.S. and AQUIPTA® in the European Union, is a calcitonin gene-related peptide (CGRP) receptor antagonist that has shown promising results in preventing migraines. It is available as an oral medication and has been approved for both episodic and chronic migraine in adults.
The interim analysis of AbbVie’s Phase 3 extension study provides valuable insights into the long-term safety, tolerability, and efficacy of atogepant for preventing migraines. The results indicate that the overall safety profile of atogepant is consistent with previous findings, with no new safety concerns identified. This is crucial information for healthcare professionals and patients, as long-term safety is a significant consideration when choosing migraine preventive therapies.
Moreover, the analysis demonstrated significant improvements in key efficacy outcomes, including a reduction in monthly acute medication use days. This suggests that atogepant has the potential to not only decrease the frequency of migraines but also decrease the reliance on acute medication use, which can have its own set of limitations and side effects.
The findings from this study are particularly relevant for the migraine population, as they offer hope for achieving long-term migraine freedom. The ability of atogepant to consistently reduce migraine days across the spectrum of the disease is a significant step forward in improving the quality of life for individuals living with migraines.
AbbVie’s plans to pursue regulatory submissions for atogepant in additional international markets indicate their commitment to making this innovative treatment more widely available. This can potentially expand access to effective migraine prevention for patients in various regions, addressing the unmet needs in the global migraine therapeutics market.
To learn more about AbbVie and its migraine prevention initiatives, visit their website: link.
For further information on migraine therapeutics and the market forecast, refer to the report by Grand View Research: link.
To explore the upcoming American Academy of Neurology (AAN) Annual Meeting, where the findings of this analysis will be presented, visit their official website: link.