Eli Lilly and Company โ Olumiant EMA EPAR public assessment report (EMEA/H/C/004085, 2017)
Eli Lilly and Company ยท 2017 ยท EMA EPAR public assessment report ยท company profile โ
Report summary
The EMA's CHMP assessment report for Olumiant (baricitinib) details its regulatory approval for moderate to severe active rheumatoid arthritis. The report covers the drug's manufacturing, quality control, and non-clinical pharmacology, highlighting its selective JAK inhibition. Non-clinical studies revealed immune suppression, hematologic changes, and reproductive toxicity, leading to a pregnancy contraindication. Clinical trials demonstrated baricitinib's efficacy, particularly the 4mg dose, showing superiority over methotrexate and adalimumab in various patient populations. However, safety concerns include increased infection rates (especially herpes zoster), malignancies, hyperlipidaemia, and myelosuppression. Risk management plans involve dose adjustments, monitoring, and post-marketing surveillance to mitigate these identified and potential risks.
Key findings โ cited to the page
| IC50 for IFN-ฮณ production inhibition in human T cells | 5.8 ยตM | baricitinib ยท p.23 |
| Grade 3 neutropenia (< 1.0 billion cells /L) | 0.3 % | ยท p.104 |
| Grade 3 lymphopenia (<0.5 billion cells /L) | 1.9 % | ยท p.104 |
| Approved indication for Olumiant | treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Olumiant may be used as monotherapy or in combination with methotrexate | Olumiant ยท Europe ยท p.14 |
| Proposed indication for Olumiant | treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who are naรฏve to, have responded inadequately to, or who are intolerant to disease-modifying anti-rheumatic drugs (including conventional or biologic DMARDs). Olumiant may be used as monotherapy or in combination with non-biologic DMARDs. | Olumiant ยท Europe ยท p.9 |
| CHMP positive opinion for marketing authorisation | 15 December 2016 | Olumiant ยท Europe ยท p.10 |
| Scientific Advice from CHMP | 26 June 2014 | Olumiant ยท Europe ยท p.10 |
| Application submission date | 22 January 2016 | Olumiant ยท Europe ยท p.9 |
| Total clearance | 17 L/h | ยท p.49 |
| Scientific Advice from CHMP | 17 November 2011 | Olumiant ยท Europe ยท p.10 |
| Eligibility to centralised procedure agreed by EMA/CHMP | 25 September 2014 | Olumiant ยท Europe ยท p.9 |
| Trial design | RCT, DB, PC, dose-ranging, parallel-group study | I4V-MC-JADC ยท United States, CZ ยท p.46 |
Source: Eli Lilly and Company โ ยท License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only โ not investment advice. Explore the Immunology library โ