lunes, 26 de marzo de 2018

FDA Approves ILUMYA (tildrakizumab-asmn) for the Treatment of Adults with Moderate-To-Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy

FDA Approves ILUMYA (tildrakizumab-asmn) for the Treatment of Adults with Moderate-To-Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy

On March 21, 2018, the U.S. Food and Drug Administration (FDA) approved ILUMYA (tildrakizumab-asmn), a humanized IgG1/k monoclonal antibody, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved recommended dosage of ILUMYA is a subcutaneous injection of 100 mg at Weeks 0, 4, and every 12 weeks thereafter. Evaluate patients for tuberculosis infection prior to initiating treatment with ILUMYA.  ILUMYA may increase the risk of infection.

Mechanism of Action (MOA), General Pharmacokinetics (PK), and Pharmacodynamics (PD) 

MOA: Tildrakizumab is an interleukin-23 antagonist.  

Dose Proportionality: Tildrakizumab pharmacokinetics increases proportionally from 50 mg to 200 mg (0.5 to 2 times the approved recommended dosage). 

Time to Steady State: Steady-state concentrations were achieved by Week 16 following administration of the approved recommended dosage. The mean (± SD) steady-state trough concentrations ranged from 1.22 ± 0.94 mcg/mL to 1.47 ± 1.12 mcg/mL. The geometric mean (CV%) steady-state Cmax was 8.1 mcg/mL (34%).

Absorption: The absolute bioavailability of tildrakizumab is 73-80% following subcutaneous injection.

Distribution: The geometric mean (CV%) volume of distribution is 10.8 L (24%).

Elimination: The geometric mean (CV%) systemic clearance is 0.32 L/day (38%), and the half-life is
approximately 23 days (23%).

Metabolism: The metabolic pathway of tildrakizumab has not been characterized. As a humanized IgG1/k monoclonal antibody, tildrakizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.

Immunogenicity: Up to Week 64, approximately 6.5% of subjects treated with ILUMYA 100 mg developed antibodies to tildrakizumab. Of the subjects who developed antibodies to tildrakizumab, approximately 40% (2.5% of all subjects receiving ILUMYA) had antibodies that were classified as neutralizing. Development of neutralizing antibodies to tildrakizumab was associated with lower serum tildrakizumab concentrations and reduced efficacy.

Use in Specific Populations

Tildrakizumab concentrations were lower in subjects with higher body weight.

No clinically significant differences in the pharmacokinetics of tildrakizumab were observed based on age (≥ 18 years). No specific studies have been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of tildrakizumab.

Efficacy and Safety

Efficacy of ILUMYA was demonstrated in two multicenter, randomized, double-blind, placebo-controlled trials in adults with plaque psoriasis. Additional information regarding efficacy trials can be found in the full prescribing information linked below.

Most common (≥ 1% and at a higher rate than placebo) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea.
Full prescribing information is available at

Visit Drugs@FDA at for prescribing and patient information, approval letters, reviews and other information for FDA-approved drug products, which are often available shortly following approval. 

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at, by faxing (1-800-FDA-0178), or by mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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