WASHINGTON -- An immune modulator called ixekizumab (Taltz) received FDA approval for treatment of moderate-to-severe plaque psoriasis in adults.
Ixekizumab binds to interleukin 17-A to block inflammation, which is a hallmark of plaque psoriasis.
, the FDA said the drug's "safety and efficacy were established in three randomized, placebo-controlled clinical trials with a total of 3,866 participants with plaque psoriasis who were candidates for systemic or phototherapy therapy. The results showed that Taltz achieved greater clinical response than placebo, with skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin."
The drug, which was developed by Eli Lilly and Company, is administered by injection and because it suppresses the immune system, the FDA is requiring a Medication Guide for patients to warn about increased risk of infection, as well as possible serious allergic reactions.
In clinical trials, the "most common side effects include upper respiratory infections, injection site reactions and fungal (tinea) infections."