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Emgality Approval History

FDA Approved: Yes (First approved September 27, 2018)
Brand name: Emgality
Generic name: galcanezumab-gnlm
Dosage form: Injection
Company: Eli Lilly and Company
Treatment for: Migraine Prevention, Cluster Headaches

Emgality (galcanezumab-gnlm) is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine, and for the treatment of episodic cluster headache.

Development History and FDA Approval Process for Emgality

DateArticle
Jun  4, 2019Approval FDA Approves Emgality (galcanezumab-gnlm) for the Treatment of Episodic Cluster Headache
Sep 27, 2018Approval FDA Approves Emgality (galcanezumab-gnlm) for the Preventive Treatment of Migraine in Adults
Jun 27, 2018AHS 2018: Lilly's Emgality (galcanezumab-gnlm) Significantly Reduced Monthly Migraine Headache Days in Patients with Migraine Who Previously Failed Botox (onabotulinumtoxinA)
May 15, 2018Lilly's Galcanezumab Meets Primary Endpoint in Phase 3 Study Evaluating Galcanezumab for the Prevention of Episodic Cluster Headache
Apr 24, 2018AAN 2018: Lilly's Galcanezumab Significantly Reduced Monthly Migraine Headache Days in Patients with Migraine Who Previously Failed to Respond to Multiple Preventive Therapies
Dec 11, 2017FDA Accepts Biologics License Application (BLA) to Review Galcanezumab for the Prevention of Migraine in Adults
Sep  8, 2017Lilly's Galcanezumab Demonstrates Positive Long-Term Safety Results For Up To 12 Months In Patients With Migraine
Jun 10, 2017Lilly's Galcanezumab Significantly Reduces Number Of Migraine Headache Days For Patients With Migraine: New Results Presented At AHS
May 12, 2017Lilly Announces Positive Results for Three Phase 3 Studies of Galcanezumab for the Prevention of Episodic and Chronic Migraine

Further information

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