AbbVie recently shared interim results from the Phase III trials for its medication,
Qulipta (atogepant), a
calcitonin gene-related peptide receptor antagonist. The drug is designed for the prevention of
chronic and episodic migraines and has shown promising long-term safety and efficacy. Over the course of 13 to 16 weeks, 70% of the patients experienced a significant reduction in the frequency of their migraines, with an average improvement of 8.5 days per month. These positive outcomes were sustained throughout the 48-week open-label treatment period.
In terms of safety, the drug did not present any new concerns and its side effects were in line with previous findings, with common ones being
COVID-19,
nasopharyngitis, and
constipation. AbbVie's vice president of neuroscience development, Dawn Carlson, emphasized the importance of striving for migraine freedom and recognized the interim analysis as a step in that direction.
AbbVie is also pursuing further regulatory approvals for Qulipta in different global markets. The interim data is part of a larger Phase III study, an open-label, 156-week extension involving nearly 600 patients. The drug's efficacy was assessed through electronic diary entries at various intervals.
Qulipta is an orally administered small molecule that targets the calcitonin gene-related peptide (CGRP) receptor, which is implicated in migraine pathogenesis by affecting blood vessel dilation and inflammatory mediator release. By blocking this receptor, Qulipta can potentially reduce the sensitivity of neurons to
pain. The drug received FDA approval in September 2021 for episodic migraine prevention.
Additionally, the UK's National Institute for Health Care and Excellence (NICE) has approved Qulipta for migraine prevention in adults with at least four migraine days per month. According to NICE's guidance, the drug should be discontinued if there is no significant reduction in migraine frequency after 12 weeks of treatment.
AbbVie has also agreed to provide Qulipta to the UK's National Health Service at a discounted rate, although the specifics of the discount have not been disclosed. The company continues to explore the potential of Qulipta in addressing the needs of migraine patients worldwide.
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