FDA Approves First Cluster Headache Treatment

Earlier this month, the FDA approved the first ever migraine drug, galcanezumab-gnlm (Emgality, Lilly) indicated to treat cluster headaches.

According to a press release, cluster headaches are characterized by the sudden onset of severe to very severe pain on one side of the head. The pain can be felt in the orbital, suborbital, and/or temporal regions and can also be accompanied by symptoms on the same side of the body, such as eye redness, nasal congestion, runny nose, etc.

“Episodic cluster headache can be devastating. The approval of Emgality for the treatment of episodic cluster headache is an important milestone as it provides a new treatment option, which has been long-awaited by those impacted by this disease,” Christi Shaw, president, Lilly Bio-Medicines, said in a statement.

Cluster headaches are also notoriously challenging to diagnose, and on average may take 5 years or more to definitively diagnose. When a patient experiences a cluster period, it can span 2 weeks to 3 months with attacks lasting 15 minutes to 180 minutes, occurring once every other day or up to 8 times per day. At present, up to 250,000 people are living with this disease in the United States.

The FDA-approved galcanezumab based off of data from a randomized, 9-week, double-blind study in which 106 patients were randomized 1:1 to receive once-monthly injections of galcanezumab 300 mg (n = 49) or placebo (n = 57). Patients in the galcanezumab arm experienced a baseline number of 17.8 cluster headaches while patients in the placebo arm had 17.3.

Patients taking galcanezumab experienced an average of 8.7 fewer weekly cluster headache attacks over weeks 1 to 3 compared with 5.2 fewer weekly attacks for patients on placebo (P = 0.036). By week 3, 71.4% of patients in the galcanezumab arm had their weekly cluster headache attacks cut in half or more from baseline versus only 52.6% of patients taking placebo in the same time period.

“For years, there have been few therapeutic options to offer patients for the treatment of episodic cluster headache. With [this] approval, physicians are now armed with an FDA-approved medication that has the potential to help patients living with this condition by reducing the frequency of cluster attacks,” David Kudrow, MD, director of the California Medical Clinical for Headache, said in a statement.