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Atogepant approved in the EU for migraine prophylaxis

Atogepant (brand name Aquipta) has been approved in the European Union (EU) as a preventative treatment for migraine in adults, its manufacturer AbbVie has announced.

This is the first and only once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) to gain EU approval and it is indicated for migraine prophylaxis in adults who experience four or more migraine days per month.

Commenting on atogepant’s approval, Roopal Thakkar, senior vice president, development and regulatory affairs, and chief medical officer at AbbVie, said: ‘The European Commission approval of Aquipta is a significant milestone for people suffering from four or more migraine days per month as it provides a once-daily treatment option that can reduce the number of migraine days and the associated pain they experience.‘

Atogepant is already approved in the United States for both chronic and episodic migraine and in Canada for episodic migraine under the brand name Qulipta.

In the UK, draft guidance from NICE has approved another oral gepant, rimegepant, for episodic migraine.

Chronic migraine is characterised by 15 or more headache days per month and at least eight migraine days, while episodic migraine refers to people with migraine who have fewer than 15 headache days per month.

Atogepant clinical efficacy

The EU approval of atogepant was based on the findings from two pivotal phase 3 studies, PROGRESS and ADVANCE, which evaluated a 60 mg once-daily dose of the drug in adult patients with chronic migraine and episodic migraine, respectively.

In both trials, primary endpoint of a statistically significant reduction in mean monthly migraine days (MMDs) was met, compared with placebo, across the 12-week treatment period.

For example, in the PROGRESS study, the changes from baseline in MMDs was a reduction of 6.8 days with atogepant compared to 5.1 days for placebo (p = 0.0024).

In addition, data from ADVANCE showed that 59% of patients treated with atogepant achieved at least a 50% reduction in MMDs compared with 29% of patients in the placebo arm (p ≤ 0.0001).

Professor Patricia Pozo-Rosich, head of neurology section at Vall d’Hebron Hospital and Institute of Research, Spain, said: ‘The pivotal Phase 3 studies demonstrated Aquipta provides significant and sustained reduction of mean monthly migraine days. This allows people to experience relief with a simple to take once-daily tablet, including those who have had an insufficient response to prior preventative migraine treatments.‘