Pfizer's Enbrel approved in the EU for rare inflammatory disease
- Enbrel (etanercept) has been approved in the EU for treatment of patients with severe non-radiographic axial spondyloarthritis, a type of a chronic inflammatory disease that affects the spine and hip joints.
- The indication is for treatment in patients at the early stages of the disease, when there are symptoms but no structural disease-related changes.
- There are around 95,000 patients with this form of axial spondyloarthritis in the UK.
Based on 2013 sales, Enbrel is an $8.7 billion drug. It was the first tumor necrosis factor (TNF) inhibitor used to treat autoimmune diseases, including moderate-to-severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, and plague psoriasis.
The latest indication is based on strong clinical data showing a 32.4% improvement (vs. 15% for placebo) in measures of disease intensity and function, as well as inflammation, over a 12-week period. Enbrel has become an important go-to treatment option for severely debilitating inflammatory conditions.
- Pharma Times EU clears Enbrel for early axial spondyloarthritis