The supplemental Biologics License Application (sBLA) for Emgality (galcanezumab-gnlm; Lilly) has been granted Priority Review by the Food and Drug Administration (FDA) for the preventive treatment of episodic cluster headache in adults.

The sBLA includes data from a phase 3 study that included 106 patients with episodic cluster headache. Results from the study showed that patients treated with galcanezumab experienced statistically significant differences in the reduction of weekly cluster headache attacks compared with patients who received placebo (primary endpoint).

“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, MD, vice president, Neurology Development, Lilly Bio-Medicines. Currently, there are no FDA-approved preventive medications for episodic cluster headache.

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Emgality, a calcitonin gene-related peptide (CGRP) antagonist, is indicated for the preventive treatment of migraine in adults. It is supplied in 120mg/mL single-dose prefilled pens as well as prefilled syringes. The treatment is intended for patient self-administration via subcutaneous injection.

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