Novartis announced today that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for two new indications –– the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful, and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal bone damage caused by years of inflammation.
See the Press Release
The first biologic medication to be approved for ankylosing spondylitis was the TNF inhibitor, Enbrel, approved in 2003. While four additional TNF inhibitors have been approved for ankylosing spondylitis and other spondyloarthritis conditions since then, TNF inhibitors remain the sole biologic medications available for these conditions.
That may soon be changing as a new kind of biologic, an IL-17 Inhibitor, is being researched with promising results.
The IL-17 Inhibitor, secukinumab, has done well in recent phase 3 clinical trials for ankylosing spondylitis (AS) as well as psoriatic arthritis (PsA) and is the first of its kind to have filed for FDA approval for any form of spondyloarthritis.
Secukinumab, which carries the trade name Cosentyx®, gained FDA approval for plaque psoriasis in early 2015.
How These Medications Work
Both IL-17 and TNFα are inflammatory cytokines (cell signaling molecules) that, as the name implies, signal to activate inflammation throughout the body, modulating or altering the immune system response. Inflammatory cytokines play an important role; however, when there is an overabundance of these, as has been described in inflammatory disease, they can cause harm to the body if left unchecked.
IL-17 and TNFα cytokines signal to specific immune cells directing them to activate inflammation, with each cytokine being responsible for signaling to a different set of cells. IL-17 and TNF inhibitor medications work by targeting their respective cytokines, obstructing their signaling pathways, and by this mechanism seek to reduce inflammation. Since Secukinumab targets different cytokines than the TNF inhibitors, the hope is that this newer medication will help those who haven’t responded well to the TNF inhibitors, or are not able to tolerate them.
Novartis, who manufacturers secukinumab, has applied to the FDA for approval of the new medication for the treatment of ankylosing spondylitis and psoriatic arthritis in the US. We will keep you posted on new developments on the pending FDA decision.