Jylamvo

Immunology· 38 cited findings· 1 source document

Company: Oresund

What the regulatory reviews say

Jylamvo is indicated for active rheumatoid arthritis in individuals aged 3 years and over. The application for Jylamvo was submitted on 4 December 2014, with a positive opinion for Marketing Authorisation issued on 26 January 2017. The shelf life of the drug is 20 months, with an in-use shelf life of 3 months.

Efficacy studies reported a Cmax mean ratio of 102.55% (90% confidence interval: 95.46% to 110.17%) and an AUC(0-t) mean ratio of 97.2% (90% confidence interval: 89.68% to 105.35%). Another finding for AUC(0-t) mean ratio was 98.86% (90% confidence interval: 93.96% to 104.00%). These findings are based on studies involving 24 subjects.

Safety data from one study reported 13 adverse events, with 3 related to the study drug. There were no serious adverse events or withdrawals due to adverse events in this study. Another safety assessment reported 0 adverse events, 0 deaths, 0 serious adverse events, and 0 withdrawals due to adverse events.

Key figures — cited to the source page

Cmax mean ratio	102.55	Oresund — Jylamvo EMA EPAR public assessment report (EMEA/H/, p.19
Cmax 90% confidence interval	95.46; 110.17	Oresund — Jylamvo EMA EPAR public assessment report (EMEA/H/, p.19
AUC(0-t) mean ratio	97.2	Oresund — Jylamvo EMA EPAR public assessment report (EMEA/H/, p.19
AUC(0-t) 90% confidence interval	89.68; 105.35	Oresund — Jylamvo EMA EPAR public assessment report (EMEA/H/, p.19
Adverse events	13	Oresund — Jylamvo EMA EPAR public assessment report (EMEA/H/, p.19
Adverse events related to study drug	3	Oresund — Jylamvo EMA EPAR public assessment report (EMEA/H/, p.19
Serious adverse events	0	Oresund — Jylamvo EMA EPAR public assessment report (EMEA/H/, p.19
Approved indication for Jylamvo	Active rheumatoid arthritis	Oresund — Jylamvo EMA EPAR public assessment report (EMEA/H/, p.30

Source documents

Oresund — Jylamvo EMA EPAR public assessment report (EMEA/H/C/003756, 2017) (2017)

Explore the full evidence

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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.