Lyumjev(LY900014)
Metabolic· 1091 cited findings· 2 source documents
Company: Eli Lilly and Company →
What the regulatory reviews say
Lyumjev (LY900014) is indicated for the treatment of diabetes mellitus in adults. The marketing authorization application was submitted on 8 March 2019, with a CHMP positive opinion on 30 January 2020, finding a favourable benefit-risk balance. Dosage strengths are 100 units/mL and 200 units/mL.
Clinical pharmacology trials included 421 healthy subjects and 342 patients with T1D or T2D exposed to LY900014. In Phase 3 studies, 1165 patients received LY900014 out of a total of 1944 patients receiving study drug. The absolute bioavailability of insulin lispro following subcutaneous injection of LY900014 was 65%. The ratio of Least Squares Geometric Means for AUC(0-∞) Deltoid/Abdominal Wall was 1.03 (90% CI: 0.993, 1.08), and for Thigh/Abdominal Wall was 1.00 (90% CI: 0.962, 1.04).
Safety data indicated a discontinuation rate of 5.3% and 4.8%. The rate of documented symptomatic hypoglycaemia (<3.0 mmol/L) for LY900014 was 6.71 Rate/year, compared to 7.35 Rate/year for Humalog. All documented hypoglycaemia rates were 12.46 Rate/year for LY900014 and 13.48 Rate/year for Humalog. Treatment-emergent ADA at EOT(w26) was 32.8% for LY900014 and 32.0% for Humalog.
Key figures — cited to the source page
| Absolute bioavailability of insulin lispro following SC injection of LY900014 | 65 | Eli Lilly and Company — Lyumjev (previously Liumjev) EMA EPA, p.36 |
| Ratio of Least Squares Geometric Means for AUC(0-∞) Deltoid/Abdominal Wall | 1.03 | Eli Lilly and Company — Lyumjev (previously Liumjev) EMA EPA, p.37 |
| 90% CI for AUC(0-∞) Deltoid/Abdominal Wall | 0.993, 1.08 | Eli Lilly and Company — Lyumjev (previously Liumjev) EMA EPA, p.37 |
| Documented symptomatic hypoglycaemia (<3.0 mmol/L) rate (LY900014) | 6.71 | Eli Lilly and Company — Lyumjev (previously Liumjev) EMA EPA, p.168 |
| Documented symptomatic hypoglycaemia (<3.0 mmol/L) rate (Humalog) | 7.35 | Eli Lilly and Company — Lyumjev (previously Liumjev) EMA EPA, p.168 |
| Treatment-emergent ADA at EOT(w26) (LY900014) | 32.8 | Eli Lilly and Company — Lyumjev (previously Liumjev) EMA EPA, p.171 |
| Treatment-emergent ADA at EOT(w26) (Humalog) | 32.0 | Eli Lilly and Company — Lyumjev (previously Liumjev) EMA EPA, p.171 |
| CHMP positive opinion date | 30 January 2020 | Eli Lilly and Company — Lyumjev (previously Liumjev) EMA EPA, p.9 |
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.