Post-marketing data on CGRP inhibitors show paucity of data and additional risks from chronic biologic usePost-marketing review highlights safety gaps for migraine CGRP drugs

Pharmacovigilance practices are essential for the rational use of medicines; this is even more true in the field of biologics. An ideal pharmacovigilance activity should cover all life phases of a drug to obtain more information on efficacy and safety by overcoming the limitations of pre-marketing studies. Active pharmacovigilance carried out during the post-marketing phase aims to fill these gaps by using continuous and pre-organized processes to fully identify the number of adverse events. In recent years, the number of biologic drugs approved by the Food and Drug Administration (FDA) has increased greatly. In the last decade, there has been a growing interest in identifying monoclonal antibodies against Calcitonin Gene-Related Peptide (CGRP) for treating migraines. However, pharmacovigilance on these biologics suffers from a paucity of data, and the limitations of pre-marketing experience, the additional risks associated with the intrinsic characteristics of biologic compounds, and the chronic use of most of these drugs make intensive and continuous pharmacovigilance activity necessary. This review aims to bring together all data on the efficacy and safety of biologics used to treat migraine. Both pre-marketing clinical trials and real-world post-marketing studies will be examined to provide a comprehensive overview of the data in the literature.