The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for AbbVie’s Aquipta (atogepant) for the prophylaxis of migraine in adults.
Aquipta is an oral calcitonin gene-related peptide receptor antagonist and is indicated for use once a day in patients with a minimum of four migraine episodes in a month.
The latest development is based on data from two Phase III clinical trials, ADVANCE and PROGRESS, which assessed a 60mg once-a-day dose of atogepant in adults with episodic and chronic migraine, respectively.
Trial data showed that Aquipta offered a substantial decline in mean monthly migraine days from baseline to 12 weeks.
The treatment also provided decline from baseline in mean monthly headache days and acute medication days.
In the trials, Atogepant was found to be well tolerated without any serious adverse events reported. Constipation, nausea and fatigue were the most frequently observed adverse reactions in trial subjects.
AbbVie UK medical director Belinda Byrne said: “There is a common misconception that migraine is ‘just a headache’, but for many patients migraine has a devastating impact on their everyday life.
“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.”
In August 2023, the company received approval from the European Commission for Aquipta for the same indication for use in the EU.