Eli Lilly and Company — Taltz FDA Review (BLA125521, ORIG 1, 2016)
Eli Lilly and Company · 2016 · FDA Review (openFDA) · company profile →
Report summary
The FDA review of Eli Lilly's BLA for ixekizumab (Taltz) for moderate to severe plaque psoriasis concluded with a recommendation for approval. Three pivotal Phase 3 trials (RHAZ, RHBA, RHBC) demonstrated Taltz's superior efficacy over placebo and etanercept, with an acceptable benefit-risk profile. The Itch NRS was validated for labeling claims. Safety data, including adverse events, laboratory findings, and specific concerns like infections, suicidality, and inflammatory bowel disease, were extensively reviewed. While some adverse events, such as neutropenia and injection site reactions, were more frequent with ixekizumab, serious adverse event rates were comparable to placebo. Concerns regarding suicidality and IBD flares were noted, but a definitive causal link was not established, though post-market monitoring was recommended. Immunogenicity was observed in approximately 20% of patients, impacting efficacy in some. Overall, Taltz's safety profile was deemed similar to other biologics for plaque psoriasis.
Key findings — cited to the page
| Grade 3 neutropenia (ANC) | 0.66 x 10^9/L | · p.158 |
| Psoriasis patients reporting significant itching and irritation | 66 % | · p.45 |
| ANC recovery to Grade 2 range | 1.22 x 10^9/L | · p.158 |
| Grade 3 thrombocytopenia (platelet count) | 47 X 10^9/L | · p.158 |
| Grade 4 neutropenia (ANC) | 0.48 x 10^9/L | · p.158 |
| Grade 4 neutropenia (ANC) | 0.49 x 10^9/L | · p.158 |
| Indication | Moderate to severe plaque psoriasis | Taltz · p.2 |
| Sponsor | Eli Lilly and Company | Taltz · p.2 |
| Review Completion Date | January 7, 2016 | Taltz · p.2 |
| BLA submission number | 125521 | Taltz (ixekizumab) · p.55 |
| Randomization pattern | 2:2:1:2 | RHBA and RHBC · Global · p.96 |
| Proportion of placebo group meeting responder definition (Itch NRS reduction) at Week 12 | 10% % | Taltz · p.17 |
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 →