Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental Biologics License Application (sBLA) for Emgality® (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache in adults. Priority Review aims to expedite the review of applications for drugs that, if approved, could potentially represent a significant advancement in treatment for a serious condition.
The sBLA is based on data from a Phase 3 study that evaluated the safety and efficacy of Emgality (galcanezumab-gnlm) injection 300mg in 106 adult patients with episodic cluster headache. Emgality was previously granted Breakthrough Therapy Designation by the FDA in September 2018 for the preventive treatment of episodic cluster headache, indicating the significant unmet need for this debilitating condition for which there are currently no approved preventive medications.
"Cluster headache is a severely disabling and excruciatingly painful neurological disorder. Few treatment options are available, and only a limited body of research from rigorous clinical trials exists. We are pleased the FDA has granted Priority Review for our sBLA, acknowledging the need for new treatments for this devastating disease and bringing us closer to potentially offering a preventive treatment option for these patients," said Gudarz Davar, M.D., vice president, Neurology Development, Lilly Bio-Medicines.
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Cluster headache belongs to the group of primary headache disorders called trigeminal autonomic cephalalgias, and people with episodic cluster headache represent 85 to 90 percent of cluster headache sufferers, a disabling disorder with a prevalence of approximately 124 per 100,000 adults. Cluster headache is under-recognized and often misdiagnosed. Currently, there are no approved preventive medications for episodic cluster headache in the U.S.
"The pain associated with cluster headache can be agonizing and crippling, with deep searing, burning, and stabbing pain, leaving people feeling desperate for new preventive treatment options. On behalf of the patient community, we are grateful to Lilly for their commitment to researching and working with regulatory authorities to potentially deliver a preventive treatment option for those living with episodic cluster headache," said Bob Wold, a person living with cluster headache and the founder of Clusterbusters, Inc.
Emgality was approved by the FDA in September 2018 for the preventive treatment of migraine in adults. Migraine is a neurologic disease characterized by recurrent episodes of severe headache. More than 30 million American adults suffer from migraine. Lilly is recruiting for Phase 3 studies evaluating Emgality for the prevention of migraine in children and adolescents (ages six to 17).