Post-marketing drug utilization study for galcanezumab
Description
- Galcanezumab is a humanised monoclonal antibody against human calcitonin gene-related peptide and is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month and is currently under evaluation for the preventive treatment of episodic cluster headache. As migraine and cluster headache are chronic conditions, continuous or intermittent long-term treatment is anticipated in routine clinical practice. Exposure to galcanezumab was limited in clinical trials. Therefore, infrequent adverse effects and effects which have a longer latency period, such as serious hypersensitivity and/or malignancy, could occur in real-world practice. Additionally, patients with recent cardiovascular events and/or serious cardiovascular risks as well as patients over the age of 65 years, who were excluded from the clinical trial population, might be part of the user population in everyday clinical practice. The implications of long-term treatment with galcanezumab are unknown, including the impact on long-term safety. As a result, the long-term safety of galcanezumab in larger patient populations requires further characterisation.
The purpose of this multi-centre retrospective cohort study is to evaluate the utilisation and safety of galcanezumab with respect to serious hypersensitivity events and long-term safety (up to 5 years), including malignancy and cardiovascular events in routine clinical practice in Europe. In a consortium of seven European databases, the study assesses the utilization of galcanezumab along with other concomitant medication among patients with severe migraine during the follow-up. For each patient, the incidence of safety events (hypersensitivity reactions, cardiovascular events) and malignancies are recorded.
(Estimated end of project: December 2026)
Funding period
- Begin: March 2019
End: December 2026
Sponsor
- Pharmaceutical industry