Eli Lilly and Company — Taltz EMA EPAR variation assessment report (EMEA/H/C/003943, 2016)
Eli Lilly and Company · 2016 · EMA EPAR variation assessment report · company profile →
Report summary
This report details Eli Lilly and Co.'s Type II variation application for Taltz (ixekizumab), driven by final data from the IXORA-PEDS pediatric psoriasis study (I1F-MC-RHCD). The application updates the Summary of Product Characteristics (SmPC), specifically sections 4.8 (Undesirable effects) and 5.1 (Pharmacodynamic properties). Key updates include information on pediatric exposure and sustained efficacy (PASI 75 and sPGA (0,1) at weeks 60 and 108) in pediatric plaque psoriasis patients. Additionally, the variation incorporates updated excipient information.
Key findings — cited to the page
| Ixekizumab US approval date | 22 March 2016 | Ixekizumab · United States · p.7 |
| Application submission date | 09 January 2026 | Taltz (ixekizumab) variation · p.3 |
| Total patients treated with Taltz across studies | 8956 patients | Taltz clinical studies · p.3 |
| Patients exposed to Taltz for at least one year | 6385 patients | Taltz clinical studies · p.3 |
| Cumulative adult patient years of exposure to Taltz | 19833 patient years | Taltz clinical studies · p.3 |
| Cumulative children exposed to Taltz | 196 children | Taltz clinical studies · p.3 |
| Cumulative children patient years of exposure to Taltz | 207343 patient years | Taltz clinical studies · p.3 |
| PASI 75 response rate | 83.0 % | IXORA-PEDS · p.4 |
| PASI 75 response rate | 76.6 % | IXORA-PEDS · p.4 |
| sPGA (0,1) response rate | 74.5 % | IXORA-PEDS · p.4 |
| sPGA (0,1) response rate | 68.1 % | IXORA-PEDS · p.4 |
| Ixekizumab EU approval date | 25 April 2016 | Ixekizumab · EU · p.7 |
Source: Eli Lilly and Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →