Eli Lilly’s Emgality approved in the US for episodic cluster headache
pharmafile | June 5, 2019 | News story | Research and Development, Sales and Marketing | Eli Lilly, Emgality, episodic cluster headache, migraine, pharma
Eli Lilly’s Emgality (galcanezumab-gnlm) self-administered injection solution has secured approval in the US for the treatment of episodic cluster headache, it has emerged.
The therapy showed its efficacy in the approved indication in a trial of 106 patients. Participants were measured for their average number of cluster headaches per week for three weeks to establish a baseline; it was found that Lilly’s drug reduced the average number of attacks by 8.7 on average from baseline, compared to a reduction of 5.2 with placebo.
However, Lilly also noted that the drug carries a risk of hypersensitivity, and that treatment should be discontinued if such a reaction occurs.
Characterised by clustered headache attacks which often repeat at the same time of days for weeks or even months and generally lasting between 15 minutes and three hours, cluster headaches can cause extreme pain with symptoms including bloodshot or tearing eyes, drooping of the eyelids, nasal congestion and facial sweating.
“Emgality provides patients with the first FDA-approved drug that reduces the frequency of attacks of episodic cluster headache, an extremely painful and often debilitating condition,” said Dr Eric Bastings, Deputy Director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to continuing to work with drug developers to bring treatments for unmet medical needs to patients.”
This latest US approval for Emgality follows the FDA’s decision in September last year to authorise the treatment for the prevention of migraine in adult patients.
Matt Fellows
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