Eli Lilly and Company — Olumiant FDA Review (NDA207924, ORIG 1, 2018)
Eli Lilly and Company · 2018 · FDA Review (openFDA) · company profile →
Report summary
The FDA Medical Review of Eli Lilly's Olumiant (baricitinib) for rheumatoid arthritis, NDA 207924, details its mechanism as a JAK inhibitor and evaluates efficacy and safety across multiple Phase 2 and 3 trials (JADC, JADA, JADN, JADV, JADX, JADW, JADZ). While both 2 mg and 4 mg doses demonstrated efficacy in improving RA symptoms and radiographic progression, significant safety concerns emerged. These include dose-related increases in liver enzymes, bilirubin, lipid parameters, and platelet counts. The review highlights a unique thrombosis risk, higher rates of infections (including opportunistic and herpes zoster), and potential for malignancy. Concerns were raised regarding the adequacy of safety data for the 2 mg dose, the consistency of efficacy separation between doses, and the overall risk/benefit profile, leading to discussions about labeling, post-marketing studies, and a potential boxed warning for serious infections and malignancy.
Key findings — cited to the page
| Proportion of placebo patients with Grade ≥1 lymphopenia in BARI 4 mg analysis set | 32 % | BARI 4 mg analysis set · p.393 |
| Proportion of baricitinib 4 mg patients with Grade ≥1 lymphopenia in BARI 4 mg analysis set | 28 % | BARI 4 mg analysis set · p.393 |
| Number of patients who developed grade 4 neutropenia (ANC<500/mm3) | 3 | · p.394 |
| Priority or Standard | Standard | Olumiant (baricitinib) · p.94 |
| NDA Application Number | 207924 | Olumiant (baricitinib) · p.94 |
| Application Type | NDA | Olumiant (baricitinib) · p.94 |
| Tofacitinib approval date (Xeljanz) | November of 2012 | Tofacitinib (Xeljanz) · p.4 |
| Application Number | 207924Orig1s000 | Baricitinib · p.1 |
| NDA Number | 207-924 | Baricitinib · p.2 |
| Proposed Indication | Treatment of adults with rheumatoid arthritis (RA) | Baricitinib · p.2 |
| Review Completion Date | April 7th, 2017 | · p.2 |
| Tofacitinib approval date (Xeljanz) | November of 2012 | Tofacitinib (Xeljanz) · 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 Immunology library →