FDA Approves New, Citrate-Free Formulation of Psoriasis Therapy

A new, citrate-free formulation of ixekizumab injection 80 mg/mL was approved by the US Food and Drug Administration (FDA) and is now available for patients with autoimmune diseases, according to a press release by Lilly.

Ixekizumab is a humanized monoclonal antibody and IL-17A antagonist used for the treatment of plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS), and nonradiographic axial spondyloarthritis (nrAxSpa).

The newly approved citrate-free formulation has the same active ingredient as the original but reduced the injection site pain some patients experience. The new formulation was associated with an 86% decrease in a visual analog scale of pain, according to the press release.

Additionally, the citrate-free formulation’s safety profile was consistent with that of the original formulation.

“Today is an exciting milestone for the nearly 30 million people around the world who live with the challenging symptoms of these autoimmune diseases that affect the skin and joints," said April Armstrong, MD, MPH, professor of dermatology, associate dean of clinical research, Keck School of Medicine at the University of Southern California. “The availability of [ixekizumab] as a citrate-free formulation represents an important advance in patient care that will allow more patients to experience less injection site pain."

Ixekizumab was first approved by the FDA in 2016. It is indicated for adults and children at least 6 years of age who have moderate to severe plaque psoriasis and are eligible for systemic therapy or phototherapy, as well as adults with active PsA, AS, and nrAxSpa who are showing signs of inflammation.

Per the press release, the citrate-free formulation is now being distributed across the United States and should be broadly available for patients by the end of August 2022.

Reference:
Lilly's Taltz® (ixekizumab) now available in new, citrate-free formulation to reduce injection site pain for improved patient experience. News release. Eli Lilly and Company; August 8, 2022.