Treats migraine. BLA 761063, held by Eli Lilly And Co. Galcanezumab-Gnlm.
As of Nov 13, 2026, BLA 761063 (Emgality), held by Eli Lilly And Co, was first approved by FDA on Sep 27, 2018, with 5 approved supplements and 0 published complete response letters.
EMGALITY is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. treatment of episodic cluster headache. 1.1 Migraine EMGALITY is indicated for the preventive treatment of migraine in adults. 1.2 Episodic Cluster Headache EMGALITY is indicated for the treatment of episodic cluster headache in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 4, 2019 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Sep 27, 2018 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Emgality120MG/ML · injectable;injection | Galcanezumab-Gnlm | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 5, 2026 | Supplement 13Labeling · Standard review | Approved | |
| Mar 21, 2025 | Supplement 10Labeling · Standard review | Approved | |
| May 24, 2022 | Supplement 6Labeling · Standard review | Approved | |
| Dec 5, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Jun 4, 2019 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Sep 27, 2018 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
