FDA Approves Taltz® for Treatment of Moderate-to-Severe Plaque Psoriasis (US) | Practical Law

FDA Approves Taltz® for Treatment of Moderate-to-Severe Plaque Psoriasis (US) | Practical Law

The FDA approved Eli Lilly and Company's Taltz (ixekizumab) injection 80 mg/ml for the treatment of moderate-to-severe plaque psoriasis in adults.

FDA Approves Taltz® for Treatment of Moderate-to-Severe Plaque Psoriasis (US)

Practical Law Legal Update w-001-8185 (Approx. 2 pages)

FDA Approves Taltz® for Treatment of Moderate-to-Severe Plaque Psoriasis (US)

by Practical Law Life Sciences
Published on 30 Mar 2016USA (National/Federal)
The FDA approved Eli Lilly and Company's Taltz (ixekizumab) injection 80 mg/ml for the treatment of moderate-to-severe plaque psoriasis in adults.
On March 22, 2016, the FDA approved Eli Lilly and Company's Taltz (ixekizumab) injection 80 mg/ml for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy, phototherapy, or a combination of both. Taltz is thought to work by binding to, and inhibiting, the IL-17A protein, which partially drives the underlying inflammation in psoriasis.
The approval was supported by data from three randomized, placebo-controlled trials that measured skin clearance levels in 3,866 patients with plaque psoriasis. After 12 weeks of treatment, 87-90% of patients who received Taltz had significant improvement of their psoriasis plaques, with 68-71% achieving virtually clear skin and 35-42% achieving a complete resolution of their psoriasis plaques. Only 7% of patients who received placebo had significant improvement, with 3% achieving virtually clear skin and 1% achieving a complete resolution of their psoriasis plaques. Taltz was also compared to FDA-approved etanercept and found to be statistically superior at all skin clearance levels.
Approximately 7.5 million people in the US have psoriasis, an autoimmune disorder of the skin. Of those, about 20% have moderate-to-severe plaque psoriasis, an itchy or painful condition that appears as raised, red patches of skin covered with a silver-white buildup of dead skin cells. It commonly occurs in patients with a family history of the disease and usually begins between the ages of 15 and 35.