Galcanezumab

Galcanezumab, sold under the brand name Emgality, is a humanized monoclonal antibody used for the prevention of migraine. It is also used for the treatment of cluster headaches.

A substance called calcitonin gene-related peptide (CGRP) has been shown to be involved in the development of migraine by widening blood vessels in the brain. Galcanezumab is a monoclonal antibody (a type of protein) designed to attach to and block CGRP, thereby helping blood vessels to return to their normal size. This will stop the symptoms of migraine. Galcanezumab is generally delivered through self-injections. Common side effects include injection site reactions such as pain or redness. Other side effects may include hypersensitivity reactions.

Galcanezumab was developed by Eli Lilly. It was approved for medical use in the United States and in the European Union in 2018, becoming the third calcitonin gene-related peptide (CGRP) inhibitor to be approved by the US Food and Drug Administration (FDA).

In the US, galcanezumab is indicated in adults for the preventive treatment of migraine; and for the treatment of episodic cluster headache.

In the EU, galcanezumab is indicated for the prophylaxis of migraine in adults who have at least four migraine days per month.

Common side effects include injection site reactions such as pain or redness, rarely hypersensitivity reactions.

Calcitonin gene-related peptide (CGRP) has been shown to be involved in the development of migraine by widening blood vessels in the brain. Galcanezumab is a monoclonal antibody which attaches to and blocks CGRP, thereby helping blood vessels to return to their normal size.

The US Food and Drug Administration (FDA) approved galcanezumab based on evidence from three clinical trials (Trial 1/NCT02614183, Trial 2/NCT02614196, and Trial 3/NCT02614261) in 2156 adults 18 to 65 years of age with chronic or episodic migraine headaches. Trials were conducted at 318 sites in Asia, Canada, Europe, Israel, Latin America, Puerto Rico, and the United States.