GSK plc — Benlysta EMA EPAR public assessment report (EMEA/H/C/002015, 2011)
GSK plc · 2011 · EMA EPAR public assessment report · company profile →
Report summary
This EMA public assessment report details the marketing authorization for Benlysta (belimumab) as an add-on therapy for active, autoantibody-positive systemic lupus erythematosus (SLE). It covers the product's manufacturing, quality control, and non-clinical aspects, including its mechanism of action, pharmacokinetics, and toxicology. Clinical efficacy was demonstrated in Phase 2 and 3 trials (BLISS-76, BLISS-52), showing improved SLE Responder Index (SRI) and reduced disease activity, particularly in patients with high disease activity. The safety profile includes potential adverse events like infusion reactions, infections, and psychiatric disorders, with ongoing pharmacovigilance. The benefit-risk balance supports its use, especially in specific high-disease-activity subgroups, with post-approval studies addressing long-term safety.
Key findings — cited to the page
| Grade 4 lymphopenia | 3.0 % | · p.76 |
| Grade 3 lymphopenia | 23 % | · p.76 |
| Grade 3 lymphopenia | 26 % | · p.76 |
| Grade 4 lymphopenia | 1.8 % | · p.76 |
| Grade 4 lymphopenia | 2.8 % | · p.76 |
| Grade 3 lymphopenia | 24 % | · p.76 |
| Severe AEs (Grade 3 or Grade 4) | 15 % | · p.69 |
| Scientific Advice date | 30 May 2008 | Benlysta · p.6 |
| Strength | 120 mg | Benlysta · p.2 |
| Procedure start date | 23 June 2010 | Benlysta · p.7 |
| Therapeutic indication | Add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy. | Benlysta · p.2 |
| ATC Code | L04AA26 | Benlysta · p.2 |
Source: GSK plc ↗ · 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 →