Taltz(ixekizumab)
Immunology· 1594 cited findings· 3 source documents
Company: Eli Lilly and Company →
What the regulatory reviews say
Taltz (ixekizumab) is indicated for adult patients with moderate to severe plaque psoriasis. Clinical trials demonstrated statistical superiority to placebo for primary and key secondary efficacy endpoints (p-values < 0.001). At Week 12, 10% of the placebo group met the responder definition for Itch NRS reduction.
Key efficacy findings include sPGA (0,1) response rates ranging from 73% to 83% and PASI-75 response rates ranging from 78% to 90%. In initial submissions, 10 total deaths were reported, with 5 deaths in psoriasis subjects on ixekizumab, 3 in rheumatoid arthritis subjects on ixekizumab, 1 in subjects on etanercept, and 0 in placebo subjects. An additional 3 deaths were reported in subjects exposed to ixekizumab during a 4-month safety update. Serious adverse events (SAEs) were experienced by 46 subjects in the Induction Period (Pool #1) and 48 subjects in the Maintenance Period (Pool #3). A total of 303 subjects in the All psoriasis Ixe Exposure Integrated Analysis Set (APIEIAS) and 53 subjects in the All RA Ixe Exposure Integrated Analysis Set (ARAIEIAS) experienced at least one SAE.
Regulatory actions include a waiver for pediatric studies for ages 0-5 years and a deferral for pediatric studies for ages 6 to <18 years, with a PeRC agreement date of January 27, 2016. Postmarketing Requirement (PMR) 1 has a final protocol submission date of 03/2017, study/trial completion by 09/2021, and final report submission by 03/2022. PMR 2 has a final protocol submission date of 09/2016 and study completion by 12/2021.
Key figures — cited to the source page
| Statistical superiority to placebo for primary and key secondary efficacy endpoints | p-values < 0.001 | Eli Lilly and Company — Taltz FDA Review (BLA125521, ORIG 1,, p.5 |
| Proportion of placebo group meeting responder definition (Itch NRS reduction) at Week 12 | 10% | Eli Lilly and Company — Taltz FDA Review (BLA125521, ORIG 1,, p.17 |
| sPGA (0,1) response rate | 83% | Eli Lilly and Company — Taltz FDA Review (BLA125521, ORIG 1,, p.109 |
| PASI-75 response rate | 90% | Eli Lilly and Company — Taltz FDA Review (BLA125521, ORIG 1,, p.109 |
| Total deaths reported in initial BLA submission | 10 | Eli Lilly and Company — Taltz FDA Review (BLA125521, ORIG 1,, p.123 |
| Deaths in psoriasis subjects on Ixe (initial submission) | 5 | Eli Lilly and Company — Taltz FDA Review (BLA125521, ORIG 1,, p.123 |
| Deaths in placebo subjects (initial submission) | 0 | Eli Lilly and Company — Taltz FDA Review (BLA125521, ORIG 1,, p.123 |
| Waiver for pediatric studies | 0-5 years of age | ELI LILLY AND CO — Taltz FDA Summary Review (NDA/BLA 125521,, p.17 |
Source documents
Compared with
Explore the full evidence
All 1594 cited findings for Taltz — searchable, comparable and answerable in plain language — are in the Immunology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.