The therapy has been developed for the treatment of migraine among adults
AbbVie has revealed that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for its Aquipta therapy.
The drug, also known as atogepant, has been developed for the treatment of migraine among adults who have at least four ‘migraine days’ every month.
The authorisation has been supported by data from two pivotal phase 3 clinical trials analysing atogepant, taken once-daily, by adults living with both episodic and chronic forms of migraine.
Across the research, the treatment met its primary endpoint of a change from baseline in average monthly migraine days across 12 weeks when compared to a placebo. Furthermore, the treatment achieved significant decreases from baseline in several secondary efficacy endpoints.
Atogepant was also generally well tolerated, with the most frequently reported adverse reactions being constipation, nausea and fatigue. The majority of these events were recorded as mild, while none were considered serious.
Belinda Byrne, medical director at AbbVie UK, reflected on how disruptive the condition could be on the lives of patients: “There is a common misconception that migraine is ‘just a headache,’ but for many patients, migraine has a devastating impact on their everyday life.”
She continued: “AbbVie is committed to advancing the standards of care for people living with migraine and we are delighted that the MHRA has provided marketing authorisation for this new medication. We are currently working with the regulatory authorities to bring this potential treatment to eligible patients as soon as possible.”
Professor Peter Goadsby, honorary consultant neurologist at King’s College Hospital, commented: “Many patients struggle for years to find an effective treatment. During this time, many are resigned to living with the debilitating effects of migraine; it shouldn’t be this way.”
He concluded: “This marketing authorisation is an important step for the migraine community, increasing the range of treatment options that we can prescribe to them.”
Migraine is a very painful and severe long-term health condition which impacts on around one in seven individuals across the UK.
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