FDA approved ixekizumab (Taltz, Eli Lilly and Co.) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
FDA approved ixekizumab (Taltz, Eli Lilly and Company) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Psoriasis affects approximately 7.5 million Americans, around 20% of whom have moderate-to-severe plaque psoriasis. Plaque psoriasis is the most common form of the condition and appears as raised, red patches of skin covered with a silvery, white buildup of dead skin cells, which are often painful or itchy.
Taltz is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.
“Many people living with psoriasis are still looking for a treatment that will successfully manage the magnitude of this disease,” said Alex Azar, president, Lilly USA, LLC. “With the approval of Taltz, we are proud to provide patients with a new treatment that may help patients experience virtually or completely clear skin.”
Here are 6 facts you need to know about Taltz:
1. Taltz will be available in the United States beginning in the second quarter of 2016.
2. Taltz should not be used in patients with a previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
3. FDA's approval of Taltz was based on findings from the largest phase 3 trial program approved to date-more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries. This clinical program included three double-blind, multicenter, phase 3 studies that demonstrated the safety and efficacy of Taltz in patients with moderate-to-severe plaque psoriasis. All three studies evaluated the safety and efficacy of Taltz (80 mg every 2 weeks, following a 160-mg starting dose) compared to placebo after 12 weeks.
4. In all 3 studies, at 12 weeks, 87% to 90% of patients treated with Taltz saw a significant improvement of their psoriasis plaques. The majority of patients treated with Taltz –68% to 71%-achieved virtually clear skin and 35% to 42% of patients saw complete resolution of their psoriasis plaques. In 2 of the studies, of patients who responded to Taltz at 12 weeks, 75% consistently maintained that response at the 60-week end point.
5. Taltz was also statistically superior to US-approved etanercept at all skin clearance levels. In an integrated analysis of the US sites in the 2 active comparator studies-UNCOVER-2 and UNCOVER-3-the respective response rates for Taltz vs. U.S.-approved etanercept were 87% vs. 41% for PASI (Psoriasis Area Severity Index) 75% and 73% vs. 27% for sPGA (static Physician's Global Assessment) 0 or 1.
6. Taltz may increase the risk of infection. Patients treated with Taltz had a higher rate of infections than patients treated with placebo (27% vs. 23%). Upper-respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in patients treated with Taltz compared to placebo. Serious infections have occurred. Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations.