Atogepant – BiotechReality – Information Intelligence System for Biopharma

AbbVie reported strong results from a Phase 3 head-to-head trial, showing that atogepant (as QULIPTA®/AQUIPTA®) was superior to topiramate on all primary and secondary measures for the preventive treatment of migraine. The results represent a major benchmark in migraine therapy, sitting the CGRP receptor antagonist in place as a potentially more effective and better-tolerated choice compared to the widely used anticonvulsant. The TEMPLE study, a multicenter, randomized, double-blind trial, compared the efficacy and tolerability of atogepant (60 mg, once daily) with topiramate in adults with chronic or episodic migraine. The main study endpoint was treatment discontinuation because of adverse events, an important consideration for long-term management of migraine. Results showed that patients who received atogepant had a much lower discontinuation rate because of adverse events at 12.1% versus 29.6% for those on topiramate. This indicates a better tolerability profile for atogepant. These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine, This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease. Roopal Thakkar In addition to its tolerability, atogepant was also more efficacious at preventing attacks. A prespecified secondary endpoint indicated that 64.1% of patients on atogepant experienced a 50% or more reduction in mean monthly migraine days, a clear comparison to 39.3% of patients who experienced the same with topiramate. The research also achieved all other secondary endpoints, which supported the clinical value of atogepant. These were a statistically significant higher reduction in mean monthly migraine days and patient-reported outcomes, like the Migraine-Specific Quality of Life Questionnaire (MSQ) and the Headache Impact Test (HIT-6). The tolerability profile of atogepant in the TEMPLE study matched that established in prior clinical trials. The most frequent adverse reactions to atogepant are nausea, constipation, and fatigue. Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist administered orally. CGRP is a neuropeptide assumed to play a central role in the pathophysiology of migraine. By inhibiting the CGRP receptor, atogepant prevents migraine attacks. The favorable result of this study head-to-head is anticipated to further reinforce the role of CGRP inhibitors as a first-line treatment for migraine prevention, providing both patients and physicians with a further level of assurance in addressing this disabling neurological disease. AbbVie intends to share the complete TEMPLE study data at a future medical meeting and will speak with regulatory agencies to share these data. About AtogepantA CGRP receptor antagonist that is taken orally once daily, atogepant was created especially to treat adult migraines in a preventative manner. Areas of the neurological system linked to the pathogenesis of migraines express CGRP and its receptors. CGRP levels have been found to rise during migraine attacks. 60 nations have approved atogepant, which is sold as AQUIPTA® in the EU and QULIPTA® in the US, Canada, Israel, and Puerto Rico. Source: AbbVie Last Modified:

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AbbVie’s Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Migraine Study

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