Eli Lilly and Co. migraine drug Emgality has won U.S. approval to treat episodic cluster headaches, making it the first drug on the market to treat the painful and often debilitating condition.
The Food and Drug Administration said Tuesday it approved the injectable drug, a self-administered, non-opioid pain treatment.
It’s the latest win for Lilly, which has been pushing hard in recent years to provide treatments for pain, a relatively new area for the Indianapolis-based drugmaker.
Emgality, also known by its generic name, galcanezumab, was first approved last fall for preventive treatment of migraine in adults. It belongs to a class of drugs called CGRP inhibitors.
Emgality generated sales of $8 million in the fourth quarter and $14 million in the first quarter. Analysts predict the drug could achieve annual sales of more than $1 billion by 2024.
Cluster headaches are intense, recurring headaches that may strike several times a day, generally lasting between 15 minutes and three hours. They are often accompanied by bloodshot eyes, excessive tearing, nasal congestion and facial sweating. More than 250,000 Americans live with the ailment.
“Episodic cluster headache can be devastating,” said Christi Shaw, president of Lilly Bio-Medicines. “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 the disease.”
The FDA said the effectiveness of Emgality for episodic cluster headache was demonstrated in a clinical trial that compared the drug to placebo in 106 patients. The trial measured the average number of cluster headaches per week for three weeks and compared the average change.
During the three-week period, patients taking Emgality experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, compared to 5.2 fewer attacks for patients on placebo.
Emgality carries a list price prior to discounts of $6,900 per year for both preventive migraine treatment and cluster headaches.
Lilly shares were down 76 cents at midday Wednesday, to $116.80 each.