In a press release from Eli Lilly and Company, the company has announced recently that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (BLA) for the company’s drug ixekizumab (marketed at Taltz®). This drug will be used as a treatment for non-radiographic axial spondyloarthritis (nr-axSpA). The medication, classified as a IL-17A antagonist, is the first drug of this type to be approved for this disease.
About Axial Spondyloarthritis
Axial spondyloarthritis is an umbrella term that encompasses autoinflammatory diseases that affect the joints of the spine and the sacrum. Radiographic axial spondyloarthritis is essentially a synonym for ankylosing spondylitis. Non-radiographic axial spondyloarthritis simply refers to less advanced disease in which changes to joints are not yet visible on a radiograph. The onset of symptoms often begins in early adulthood. These symptoms may include relapsing/remitting back pain, progressive joint stiffening, fatigue, fever, and weight loss. Inflammation can spread to other parts of the body, such as the eyes, the cardiovascular system, and lungs. No cure for the disease exists, so treatment focuses on pain management and slowing disease progression. Treatment may include NSAIDs, opioids, TNF inhibitors, physical therapy, surgery, and some others. Unfortunately, most therapies can cause serious side effects with long term use. To learn more about axial spondyloarthritis, click here.
Improving Patient Lives
Many experts believe that this disease is significantly underdiagnosed and many patients may deal with inflammation and pain for years before getting diagnosed. During this time, patients often see progression of their illness and are not receiving sufficient treatment. This approval will give patients living with this disease a new option for treatment and an opportunity to see improvements to their quality of life.
The approval follows a phase 3 trial testing ixekizumab in axial spondyloarthritis in which the therapy showed meaningful improvements in disease signs and symptoms based on Assessment of Spondyloarthritis International Society 40 (ASAS40) response criteria.
Ixekizumab has shown benefit in a several autoimmune diseases. It was first approved in 2016 for moderate to severe plaque psoriasis and has also received approvals for psoriatic arthritis, ankylosing spondylitis, and children with plaque psoriasis aged six years or older.