FDA approves new psoriasis drug Taltz

March 22, 2016

The U.S. Food and Drug Administration approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. 

getty_rm_photo_of_illustration_of_psoriasis

Psoriasis is a skin condition that causes patches of skin redness and flaking. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease, and most often begins in people between the ages of 15 and 35. The most common form of psoriasis is plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white Scales.

Description

  • xekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A.
  • Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing.
  • Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each, and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule.

 CLINICAL PHARMACOLOGY

Mechanism of Action

Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds with the interleukin tion(IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of proinflammatory cytokines and chemokines.

INDICATIONS AND USAGE

TALTZ™ is a humanized interleukin-17A antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

 DOSAGE AND ADMINISTRATION

  • Administer by subcutaneous injection.
  • Recommended dose is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

DOSAGE FORMS AND STRENGTHS

Autoinjector Injection: 80 mg/mL solution in a single-dose prefilled autoinjector. Prefilled Syringe Injection: 80 mg/mL solution in a single-dose prefilled syringe.

CONTRAINDICATIONS

Serious hypersensitivity reaction to ixekizumab or to any of the excipients

WARNINGS AND PRECAUTIONS

  • Infections: Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue TALTZ until the infection resolves.
  • Tuberculosis (TB): Evaluate for TB prior to initiating treatment.
  • Hypersensitivity: If a serious allergic reaction occurs, discontinue TALTZ immediately and initiate appropriate therapy.
  • Inflammatory Bowel Disease: Crohn’s disease and ulcerative colitis, including exacerbations, occurred during clinical trials. Patients who are treated with TALTZ and have inflammatory bowel disease should be monitored closely.

ADVERSE REACTIONS

 Most common (≥1%) adverse reactions associated with TALTZ treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.

 DRUG INTERACTIONS 

Live Vaccines: Live vaccines should not be given with TALTZ.

 SAFETY & EFFICACY

Three multicenter, randomized, double-blind, placebo-controlled trials (Trials 1, 2, and 3) enrolled a total of 3866 subjects 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, a static Physician Global Assessment (sPGA) score of ≥3 in the overall assessment (plaque thickness/induration, erythema,and scaling) of psoriasis on a severity scale of 0 to 5, a Psoriasis Area and Severity Index (PASI) score ≥12. 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

 Taltz is marketed by Indanapolis, Indiana-based Eli Lilly and Company.

REFERENCE

  1. PRESS RELEASE
  2. TALTZ PRESCRIBING INFORMATION