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July 19, 2022

AbbVie seeks EMA marketing authorisation for preventive migraine therapy

The MAA is based on data from two Phase III trials of atogepant in adult patients with episodic and chronic migraine.

AbbVie has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for its atogepant for prophylaxis of migraine in adults who experience a minimum of four migraine days each month. 

An oral CGRP receptor antagonist (gepant), atogepant is developed as a preventive migraine treatment. 

The application is based on the Phase III ADVANCE and PROGRESS clinical trial analysing the safety, efficacy and tolerability of atogepant in adult patients with episodic migraine and chronic migraine, respectively.

The randomised, multicentre, placebo-controlled, double-blind, parallel-group ADVANCE trial assessed the safety, efficacy and tolerability of once a day (QD) dose of oral atogepant for the prophylaxis of episodic migraine. 

According to the findings, the trial met the primary endpoint of a statistically significant decline in mean monthly migraine days across the treatment duration of 12 weeks versus placebo. 

In addition, a higher percentage of subjects who received atogepant attained a minimum of a 50% decline in mean monthly migraine days for all tested doses versus placebo, as well as met the trial’s key secondary endpoints.

The double-blind, randomised, placebo-controlled, parallel-group PROGRESS trial analysed the safety, efficacy and tolerability of oral atogepant in adults for the prophylaxis of chronic migraine.

This trial met the primary endpoint of statistically significant decline in mean monthly migraine days from baseline versus placebo on treatment with atogepant for 12 weeks. 

Furthermore, 60mg QD and 30mg daily (BID) dose of atogepant offered statistically significant improvements across all secondary endpoints. 

In both trials, all doses were found to be well tolerated with the overall safety profiles in line with safety data reported in prior trials in episodic migraine and chronic migraine patients. 

Constipation and nausea were reported to the most common adverse events.

AbbVie neuroscience development therapeutic area head Michael Gold said: “Far too many people around the world are impacted from the debilitating challenges of migraine, which places a significant social and work-life burden for patients and care partners. 

“If approved, atogepant will provide a prophylactic treatment option for adult migraine patients suffering for more than four days a month.”

In May this year, the company filed a new drug application with the US Food and Drug Administration for ABBV-951 (foscarbidopa/foslevodopa) for treating motor fluctuations in people with advanced Parkinson’s disease.

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