Eli Lilly and Company — Taltz EMA EPAR public assessment report (EMEA/H/C/003943, 2016)
Eli Lilly and Company · 2016 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's public assessment report for Eli Lilly's Taltz (ixekizumab) details its approval for moderate to severe plaque psoriasis. The Marketing Authorisation application, submitted in April 2015, led to a positive CHMP opinion in February 2016. Quality, non-clinical, and pharmacokinetic aspects were deemed acceptable, with ixekizumab specifically neutralizing IL-17A. Clinical studies demonstrated superior efficacy over placebo and etanercept, with high PASI 75/90/100 and sPGA (0,1) response rates maintained up to 60 weeks. Safety concerns include increased Candida infections and injection site reactions, but overall, the safety profile was considered manageable, leading to the recommendation for marketing authorization.
Key findings — cited to the page
| Neutropenia Grade 2 or Worse incidence | 2.9 % | · p.140 |
| Neutropenia Grade 2 or Worse incidence | 2.4 % | · p.140 |
| Neutropenia Grade 2 or Worse incidence (PBO) | 0.5 % | · p.140 |
| Neutropenia Grade 2 or Worse incidence (ETN) | 3.9 % | · p.140 |
| Proposed indication | Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy | Taltz · p.4 |
| Legal basis for application | Article 8.3 of Directive 2001/83/EC | · p.4 |
| Application for Marketing Authorisation submission date | 23 April 2015 | Taltz · EU · p.4 |
| Procedure start date | 28 May 2015 | · p.5 |
| PRAC Rapporteur RMP Assessment Report adoption date | 10 September 2015 | · p.5 |
| Rapporteur's first Assessment Report circulation date | 14 August 2015 | · p.5 |
| Co-Rapporteur's first Assessment Report circulation date | 14 August 2015 | · p.5 |
| Scientific Advice date | 19/05/2011 | · p.4 |
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 →