Eli Lilly's Emgality Receives FDA Approval as First Treatment for Adult Episodic Cluster Headache

VCBeat (WeChat ID: vcbeat) learned from foreign media that Eli Lilly, a globally renowned biopharmaceutical company, recently announced that its new drug, Emgality injection, has received FDA approval for the treatment of cluster headache in adults. This marks the second indication approved for Emgality, following its approval for migraine, and makes it the first medication approved for treating cluster headache in adults.

Emgality is a humanized monoclonal antibody that targets calcitonin gene-related peptide (CGRP). CGRP is a neuropeptide considered to be a trigger for migraine attacks. Emgality was approved by the FDA in September 2018 for the treatment of adult migraines at a dose of 120 mg. It is also the third approved CGRP medication for treating adult migraines currently on the market, with the other two being Aimovig and Ajovy.

In the United States, approximately 250,000 adults suffer from cluster headaches annually. The condition is characterized by the sudden onset of severe unilateral head pain, accompanied by symptoms such as conjunctival injection, excessive lacrimation, ptosis, rhinorrhea, nasal congestion, and facial sweating. Cluster headache episodes typically last from two weeks to three months, occurring up to eight times per day, with each attack lasting between 15 minutes and 3 hours. Cluster headaches are generally considered "paroxysmal," causing sudden attacks in patients over a short period.

“Episodic cluster headache can be devastating for patients. The FDA’s approval of Emgality for the treatment of episodic cluster headache marks a significant milestone toward curing this condition, as it provides a new therapeutic option and offers hope for relief to patients who have long suffered from this disease,” said Christi Shaw, President of Eli Lilly, in a statement.

During the Phase 3 clinical trials of Emgality, Eli Lilly compared the mean change from baseline in the 300 mg Emgality group versus the placebo group. The trial results showed that over a three-week treatment period, patients receiving Emgality experienced a reduction of 8.7 attacks per week in cluster headache frequency from baseline, compared to a reduction of 5.2 attacks per week in the placebo group. In the Emgality group, 71.4% of patients achieved at least a 50% reduction from baseline in weekly cluster headache attacks by Week 3.

Bob Wold, founder of Clusterbusters, stated, “As a patient profoundly affected by cluster headaches, I deeply understand the sense of despair this condition brings to those of us who suffer from it. The approval of Emgality for the treatment of cluster headaches is a cause for significant celebration, as it enables us to reduce the frequency of episodic headache attacks. I extend my gratitude to Eli Lilly and Company, the FDA, and the relevant researchers for their efforts in bringing this innovative medication to market.”

It is worth noting that since its launch as a treatment for adult migraine, Emgality’s sales have consistently lagged behind those of other CGRP-targeting drugs. In the first quarter of 2019, Emgality generated $14 million in revenue, whereas the comparable CGRP therapies Aimovig and Ajovy recorded sales of $59 million and $20 million, respectively. However, this recent approval has made Emgality the sole medication approved for the treatment of cluster headaches, which is expected to boost its sales to some extent.

(Compiled by Wang Chan)