AbbVie gains EU migraine treatment approval
Posted: 17 August 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The first once-per-day oral CGRP receptor antagonist gepant treatment has been approved in the EU as a preventative treatment for both chronic and episodic migraines.
Recent EU approval means adults who have four or more migraine days per month can now access the first and only once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant). Authorisation of AbbVie’s AQUIPTA® (atogepant) by the European Commission (EC) is based on two Phase III studies which demonstrated that “AQUIPTA provides significant and sustained reduction of mean monthly migraine days [for both chronic and episodic migraines],” stated Dr Patricia Pozo-Rosich, PhD, Head of Neurology Section, Vall d’Hebron Hospital and Institute of Research in Spain.
The EC’s approval of AQUIPTA for both varieties of this condition is a “significant milestone”, according to Roopal Thakkar, Senior Vice President of Development and Regulatory Affairs and Chief Medical Officer at AbbVie.
Data from the Phase III migraine studies
Data from AbbVie’s two pivotal Phase III studies, PROGRESS and ADVANCE, evaluated 60mg once-daily (QD) AQUIPTA in adults across 12 weeks.
In the PROGRESS clinical trial, the study demonstrated that 40 percent of its 778 participants achieved at least a 50 percent reduction in mean monthly migraine days (MMDs). This was compared to 27 percent of patients in the placebo arm.
In the ADVANCE clinical trial, which evaluated 910 patients, data showed that 59 percent of patients achieved at least a 50 percent reduction in MMDs. This result was compared to 29 percent of participants given placebo.
The preventative treatment was shown to provide relief for participants who have had an insufficient response to prior preventative treatments for the condition, Dr Patricia Pozo-Rosich noted.
EU authorisation of the CGRP receptor antagonist widens AbbVie’s therapeutic portfolio of treatments in adults patients across the EU for this condition. According to the pharma company, studies have shown that CGRP levels are elevated during attacks whereby symptoms are present and selective CGRP receptor antagonists provide clinical benefit.
Currently, Atogepant is approved in the US for both types of the condition and in Canada for the episodic variety under the brand name QULIPTA®.
Related topics
Big Pharma, Biopharmaceuticals, Clinical Development, Clinical Trials, Data Analysis, Drug Development, Drug Safety, oral therapeutic candidate, Regulation & Legislation, Research & Development (R&D), Therapeutics
