ELI LILLY AND CO — Taltz FDA Summary Review (NDA/BLA 125521, 2016)
Eli Lilly and Company · 2016 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
This report summarizes the FDA review of ixekizumab (Taltz) for moderate-to-severe plaque psoriasis. Three pivotal trials demonstrated Taltz's superior efficacy over placebo and etanercept in achieving sPGA 0/1 and PASI-75 at week 12. Safety concerns included increased infections, inflammatory bowel disease, and hypersensitivity reactions, though no active tuberculosis was reported. The FDA waived studies for children 0-5 years and deferred for 6-18 years, extrapolating adult efficacy but requiring pediatric safety data. Post-marketing requirements include a pediatric PK/safety/activity study and two pregnancy outcome studies.
Key findings — cited to the page
| Postmarketing Requirement (PMR) 2: Final Protocol Submission | 09/2016 | TALTZ · p.18 |
| Postmarketing Requirement (PMR) 1: Study/Trial Completion | 09/2021 | TALTZ · p.18 |
| PeRC agreement date | January 27, 2016 | · p.17 |
| Postmarketing Requirement (PMR) 1: Final Report Submission | 03/2022 | TALTZ · p.18 |
| Postmarketing Requirement (PMR) 2: Final Report Submission | 06/2022 | TALTZ · p.18 |
| Postmarketing Requirement (PMR) 2: Study Completion | 12/2021 | TALTZ · p.18 |
| Waiver for pediatric studies | 0-5 years of age | TALTZ · p.17 |
| Deferral for pediatric studies | 6 to <18 years of age | TALTZ · p.17 |
| Postmarketing Requirement (PMR) 1: Final Protocol Submission | 03/2017 | TALTZ · p.18 |
| PASI-100 treatment effect | 39 % | RHBA trial · p.5 |
| PASI-75 treatment effect vs etanercept | 41 % | RHBC trial · US sites only · p.5 |
| PASI-100 treatment effect | 35 % | RHAZ trial · p.5 |
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 →