Eli Lilly and Company has secured approval from the US Food and Drug Administration (FDA) for Taltz (ixekizumab) to treat moderate-to-severe plaque psoriasis in adults.
Taltz, which is administered as an injection, is indicated for patients who are candidates for systemic therapy or phototherapy.
It is a humanized IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.
IL-17A is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.
The safety and efficacy of Taltz were demonstrated in three randomized, placebo-controlled trials involving over 3800 patients with plaque psoriasis.
Taltz led to significant skin clearing compared with a placebo and was statistically superior to US-approved Enbrel (etanercept) at all skin clearance levels.
The FDA center for drug evaluation and research director of the office of drug evaluation III Julie Beitz said: "Today’s approval provides patients suffering from plaque psoriasis with another important treatment option to help relieve the skin irritation and discomfort from the condition."
The agency said as Taltz is an immunotherapy, it is being approved with a Medication Guide to inform patients that they may have a greater risk for an infection, or an allergic or autoimmune condition.
Eli Lilly plans to launch Taltz in the US starting in the second quarter of this year.
Plaque psoriasis is the condition’s most common form and is characterized by raised, red patches covered with a silvery white buildup of dead skin cells.
Image: Lilly corporate headquarters in Indianapolis, Indiana. Photo: courtesy of Eli Lilly and Company.