Eli Lilly and Company — Emgality FDA Review (BLA761063, ORIG 1, 2018)
Eli Lilly and Company · 2018 · FDA Review (openFDA) · company profile →
Report summary
The FDA's clinical review of Eli Lilly's BLA 761063 for Emgality (galcanezumab) for migraine prevention recommends approval for adults. The proposed regimen is a 240 mg loading dose followed by 120 mg monthly. Efficacy was demonstrated in three Phase 3 trials (CGAG, CGAH, CGAI), showing statistically significant and clinically meaningful reductions in monthly migraine days for both episodic and chronic migraine, with onset as early as month 1. The safety profile indicates common adverse events like injection site reactions and hypersensitivity. While various serious adverse events, including cardiovascular, neurological, and psychiatric events, were observed, most were mild to moderate, and a definitive causal link to Emgality was often difficult to establish. No new safety signals were identified, and no safety concerns preclude approval at the proposed dose. Postmarketing studies, particularly for cardiovascular effects and pregnancy, are recommended.
Key findings — cited to the page
| Menstruation irregular (Placebo) | 5 | · p.109 |
| Menstruation irregular (GMB 120) | 4 | · p.109 |
| Menstruation irregular (GMB 240) | 1 | · p.109 |
| Proposed Indication | Prophylaxis of migraine headache in adults | Emgality · p.182 |
| Number of patients enrolled (total) | 1113 | I5Q-MC-CGAI · p.208 |
| Proposed Trade Name | EMGALITY | · p.2 |
| BLA submission type | 351(a) | Emgality (galcanezumab) · US · p.190 |
| Applicant Proposed Indication | Prevention of migraine | · p.2 |
| Planned Sample Size for Placebo arm | 558 patients | Study CGAI · p.256 |
| BLA Application Number | 761063 | Emgality · p.182 |
| Application Number | 761063 | Emgality (galcanezumab) · p.2 |
| Applicant Proposed Dosing Regimen | Loading dose of 240 mg, followed by 120 mg once a month | · p.2 |
Source: Eli Lilly and Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →