FDA Approves Ixekizumab for Treatment of Moderate-to-Severe Plaque Psoriasis

March 29, 2016
BioPharm International Editors

The drug is marketed by Eli Lilly in the US, and will be available at the beginning of the second quarter of 2016.

FDA approved Eli Lilly’s Taltz (ixekizumab) injection 80 mg/mL to treat adults with moderate-to-severe plaque psoriasis, on March 22, 2016.

Taltz’s active ingredient is an antibody (ixekizumab) that binds tointerleukin (IL)-17A, a protein that causes inflammation. By binding to the protein, ixekizumab is able to inhibit the inflammatory response that plays a role in the development of plaque psoriasis. According to FDA, Taltz is administered as an injection and is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected), phototherapy (ultraviolet light treatment) or a combination of both. 

Taltz’s safety and efficacy were established in three randomized, placebo-controlled clinical trials with a total of 3,866 participants from 21 countries 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 may be a direct competitor for Enbrel (etanercept). In a press announcement, Eli Lilly said Taltz was “statistically superior” to etanercept at all skin clearance levels. The company wrote, “in two active comparator studies-UNCOVER-2 and UNCOVER 3-the respective response rates for Taltz vs. U.S.-approved etanercept were 87 percent vs. 41 percent for PASI [Psoriasis Area Severity Index] 75 and 73 percent vs. 27 percent for sPGA [static Physician’s Global Assessment] 0 or 1.” The drug may also prove to be a direct competitor for Novartis’ Cosentyx (secukinumab) and AstraZeneca/Valeant’s brodalumab, which is expected to receive FDA approval in the beginning of the second quarter of 2016.

Source: FDA, Eli Lilly and Company