BETHESDA, MD 23 Mar 2016—
FDA and Eli
Lilly & Co. on March 22
announced the approval of ixekizumab injection for the treatment of
moderate-to-severe plaque psoriasis in adults who are candidates for systemic
therapy or phototherapy.
Eli Lilly and
Co. will market the biologic, an interleukin-17A antagonist, as Taltz. The
company expects the product to be available during the second quarter of this
Labeling (PDF) for ixekizumab recommends initiating
therapy with a 160-mg dose, administered as two 80-mg subcutaneous injections,
during week 0. Patients should then receive an 80-mg dose during weeks 2, 4, 6,
8, 10, and 12 of therapy, followed by 80 mg every four weeks.
treatment may increase the risk of tuberculosis (TB) and other infections. These
risks are emphasized in the FDA-required
Guide (PDF) for patients.
According to the
Medication Guide and the labeling, patients should be evaluated for TB
infection before ixekizumab treatment is initiated, and they should be
monitored for signs and symptoms of TB during and after treatment with ixekizumab.
should not be administered to patients with active TB infection. Patients with
latent TB infection should be treated for that condition before starting
treatment with ixekizumab.
also recommends that healthcare providers consider administering all
age-appropriate vaccinations for a patient before initiating ixekizumab
frequently reported adverse events associated with ixekizumab therapy in
clinical studies were injection-site reactions, upper respiratory tract
infection, nausea, and ringworm.
events reported in clinical trials included urticaria, angioedema, and other
hypersensitivity reactions and new-onset or worsening inflammatory bowel
disorders. The labeling states that ixekizumab therapy should be immediately
discontinued if a serious hypersensitivity reaction occurs during treatment.
be supplied in 80-mg single-dose autoinjectors or prefilled syringes in cartons
of one, two, or three devices each that should be refrigerated at 2–8 °C
and protected from light until use.