Galcanezumab: a humanized monoclonal antibody for the prevention of migraine and cluster headache.

Migraine is a common, painful and highly disabling neurological condition that has plagued mankind for millennia, but its pathophysiology remained largely obscure until recently. The clinical success of triptans for treating migraine and the discovery that calcitonin gene-related peptide (CGRP) plays a prominent role in migraine led to increased research interest into this disease. An important improvement has been the development of monoclonal antibodies, including galcanezumab, that bind to CGRP or to its receptor, preventing its activation. Subsequent clinical trials have reported that galcanezumab is safe and well tolerated, and is effective in reducing the frequency of migraine attacks in patients with episodic or chronic migraine. At the same time, increased study of the pathophysiology of cluster headache, a relatively rare condition with excruciatingly painful headache attacks (i.e., "suicide headaches"), led to the discovery that, as in migraine, CGRP plays an important role in its pathology. Clinical trials suggest that galcanezumab is safe and effective for the prevention of episodic cluster headache, and it is under study for chronic cluster headache. Galcanezumab is approved for the prevention of migraine in the U.S., the European Union, Canada and Mexico, and was also approved for the treatment of episodic cluster headache in the U.S.