EMGALITY
Neurology· 1016 cited findings· 1 source document
Company: Eli Lilly and Company →
What the regulatory reviews say
EMGALITY (galcanezumab) is a drug proposed for the prophylaxis of migraine headache in adults. The applicant proposed a dosing regimen of a 240 mg loading dose followed by 120 mg once a month.
Clinical trials demonstrated a reduction in monthly migraine days. The overall LS mean reduction from baseline in monthly migraine headache days was -4.8 days, compared to a -2.8 days reduction in the placebo arm. The LS mean change difference from placebo in monthly migraine headache days was -2.0.
Safety findings include injection site reactions occurring in 18 to 23% of patients, compared to 13% in the placebo group. Hypersensitivity reactions were observed in 3% of patients, with 1% discontinuing due to hypersensitivity. The elimination half-life of EMGALITY is 27 days.
Key figures — cited to the source page
| overall LS mean reduction from baseline in monthly migraine headache days | -4.8 | Eli Lilly and Company — Emgality FDA Review (BLA761063, ORIG, p.267 |
| overall LS mean reduction from baseline in monthly migraine headache days (placebo) | -2.8 | Eli Lilly and Company — Emgality FDA Review (BLA761063, ORIG, p.267 |
| LS mean change difference from placebo in monthly migraine headache days | -2.0 | Eli Lilly and Company — Emgality FDA Review (BLA761063, ORIG, p.267 |
| Injection site reactions | 18 to 23 | Eli Lilly and Company — Emgality FDA Review (BLA761063, ORIG, p.8 |
| Injection site reactions (placebo) | 13 | Eli Lilly and Company — Emgality FDA Review (BLA761063, ORIG, p.8 |
| Hypersensitivity reactions (GMB) | 3 | Eli Lilly and Company — Emgality FDA Review (BLA761063, ORIG, p.8 |
| Elimination half-life | 27 | Eli Lilly and Company — Emgality FDA Review (BLA761063, ORIG, p.115 |
| Proposed Indication | Prophylaxis of migraine headache in adults | Eli Lilly and Company — Emgality FDA Review (BLA761063, ORIG, p.182 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.