The authorisation was based on the findings from two Phase 3 trials in which the treatment met their primary endpoint of a change from baseline in mean monthly migraine days across 12 weeks compared to placebo
AbbVie received MHRA marketing authorisation for Aquipta. (Credit: AbbVie Inc.)
AbbVie has secured marketing authorisation from UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Aquipta (atogepant) to prevent migraines in adults who have at least four migraine days per month.
Aquipta is a once-daily, orally administered calcitonin gene-related peptide (CGRP) receptor antagonist.
The marketing authorisation was based on the findings from two Phase 3 clinical trials evaluating atogepant 60mg once daily in adults living with episodic (ADVANCE) and chronic (PROGRESS) migraine.
In both trials, the treatment met their primary endpoint of a change from baseline in mean monthly migraine days across 12 weeks compared to placebo.
In addition, the therapy showed significant reductions from baseline in many secondary efficacy endpoints compared to placebo including mean monthly headache days and mean monthly acute medication days.
The CGRP receptor was generally well tolerated in both studies, with mild and no serious adverse events reported.
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.”
Aquipta was assessed for the prevention of episodic migraine in a randomised, multicentre, double-blind, placebo-controlled ADVANCE study.
It randomised 910 patients 1:1:1:1 to receive Aquipta 60mg and placebo once daily for 12 weeks. Its primary endpoint was defined as the change from baseline in mean monthly migraine days (MMD) across 12 weeks.
For chronic migraine, the CGRP receptor was assessed in a randomised, multi-centre, double-blind, placebo-controlled PROGRESS study.
It randomised 1:1:1 778 patients to receive Aquipta 60 mg and placebo once daily for 12 weeks. The primary endpoint was the change from baseline in mean MMD across the 12‑week treatment period.