According to a press release from Eli Lilly and Company, the US Food and Drug Administration (FDA) recently granted market approval to Lilly’s ankylosing spondylitis drug, Taltz (ixekizumab).
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a rare inflammatory disease that is sometimes characterized by the progressive fusion of lower vertebrae in the spine, leading to what can be severe and chronic pain. Although vertebrae don’t always fuse, inflammation of the spine can lead to regular discomfort or stiffness.
To date, no specific cause of ankylosing spondylitis has been established. The reason for this, however, is probably not just the result of unlucky searches. More likely, AS is instead caused by a confluence of a number of genetic or possibly even environmental factors. Genetic factors are assumed to be at least partially in play, since people with a gene called HLA-B27 have greatly increased risk of developing ankylosing spondylitis. HLA-B27 is a gene that encodes for a protein with the same name.
HLA-B27 is a “human leukocyte antigen,” a protein found on the surface of cells that acts as a sort of identification tag to help the immune system differentiate between “friendly” cells and foreign pathogens. This lends evidence to the classification of ankylosing spondylitis as an autoimmune disease.
Although no cure exists for ankylosing spondylitis, treatments do exist that can mitigate pain and manage other symptoms. Recent studies of certain biologics suggest they may be useful for slowing the progression of AS, though not all patients respond to the same treatments.
Taltz Approved in Patients
Taltz is an 80mg/mL concentration of ixekizumab administered via injection. The FDA’s recent approval of the drug for the treatment of ankylosing spondylitis came at the conclusion of a phase 3 clinical study of the drug. The study found that Taltz reduced pain and inflammation in AS patients across the board — regardless if whether or not they had received prior treatment for the condition.
Separate arms of the study were run, sorting participants into groups depending on if they were treatment naive or if they had previously received certain treatments that produced little effect. An impressive 48% of the treatment-naive patients experienced significant improvement in their symptoms, opposed to just 18% of the control group. 25% of the group previously treated with little effect (such as those who received TNF inhibitors) responded to Taltz, opposed to just 13% in the control arm.
Dr. Philip Mease at the Swedish Medical Center in Washington state spoke highly of the recent approval. “This approval is an important milestone for patients and physicians,” Mease said. These individuals have been in need of an “…alternative to address symptoms of AS.”
Taltz was first approved by the FDA for plaque psoriasis in 2016.
What do you think of this exciting development? Does it surprise you drugs already approved for one condition may be approved to treat another condition years later? Share your thoughts with Patient Worthy!
