Monoclonal Antibodies to Prevent Migraine Headaches

Migraine is a common, chronic, neurological disorder. To prevent chronic migraine headaches, botulinum toxin has received regulatory approval. This medication requires multiple injections into specific head and neck sites. Other drugs are used in migraine prevention but patient adherence and efficacy are issues. Anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies belong to a novel class of drugs that target CGRP — a potent vasodilator — which plays a role in pain and migraines. Four anti-CGRP monoclonal antibodies are currently in development for use in the prevention of episodic and chronic migraines: eptinezumab, erenumab, fremanezumab, and galcanezumab. They have not yet been approved in any country. Phase II and phase III trial results are available for all four drugs. The evidence available to date demonstrated a statistically significant decrease in the frequency of migraines. Episodic migraine sufferers experienced one to two fewer migraine days each month. Patients with chronic migraine experienced two to two-and-one-half fewer migraine days each month. There were no safety concerns identified with these drugs. Although the cost of these drugs has not been determined, these drugs will potentially have a significant budget impact because of the high cost of biologics and the prevalence of episodic and chronic migraines.