Since the drug was first approved in 2016, nearly 130,000 people in the United States have been treated with Taltz
INDIANAPOLIS, August 8, 2022 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced the availability of a new citrate-free formulation of Taltz® (ixekizumab) injection 80 mg/mL. The new formulation, recently approved by the United States Food and Drug Administration in May 2022, includes the same active ingredient as the original formulation. The new Taltz formulation significantly reduced injection site pain experienced by some people immediately after injection, as shown by an 86% decrease in pain on a visual analogue scale (VAS) compared to the original formulation. Taltz is approved to treat adults and children six years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, adults with active psoriatic arthritis, active ankylosing spondylitis (AS) and active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
“Taltz has a long history of providing an effective treatment with a well-established safety profile that treats the symptoms of people with plaque psoriasis, psoriatic arthritis, AS and nr-axSpA,” said Ashley Diaz Granados, vice president, US Immunology at Lilly. “We are proud of our investment in research that puts the patient experience at the center. This new formulation provides yet another reason to choose Taltz, and we look forward to introducing it to patients who have not yet tried Taltz and to provide a smooth transition for those already enjoying the benefits of the drug.”
Taltz without citrate demonstrated a safety profile consistent with the original formulation. Safety information for Taltz can be found below.
Current Taltz patients will not need a new prescription and should not experience any interruption to their treatment. The new formulation is currently shipping across the United States and should be widely available to new and existing Taltz patients by the end of the month. In the meantime, the original Taltz formulation continues to be available until replaced by the citrate-free formulation. The citrate-free formulation of Taltz has been approved by the European Medicines Agency in December 2021 with several marketplaces being launched and many more planned in the coming months.
“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 skin and joints,” said April ArmstrongMD, MPH, Professor of Dermatology and Associate Dean of Clinical Research, Keck School of Medicine at the University of Southern California. “In my six years of prescribing Taltz, I have seen firsthand the significant impact Taltz has had on patients across multiple indications. The availability of Taltz in a citrate-free formulation represents a significant advancement in patient care that will allow more patients to experience less pain at the injection site.”
Lilly is committed to improving the experiences of people treated with Taltz, by providing the same active ingredient in a new citrate-free formulation. Lilly’s investment in patient-centric research is evident as Taltz has been studied in over 10,000 people in clinical trials worldwide and has been available in most markets for over five years. .1 In the United States, more people with psoriasis are treated with Taltz than any other IL-17A antagonist, adding to the nearly 130,000 people in the United States who have been treated with the drug. .2
To learn more about real success stories with Taltz, please visit Taltz.com.
IMPORTANT SAFETY INFORMATION FOR TALTZ
Taltz is contraindicated in patients who have previously had a serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Taltz can increase the risk of infection. In clinical trials of adult patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% versus 23%). A similar increased risk of infection has been observed in placebo-controlled trials in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondylitis, and pediatric patients with plaque psoriasis. Serious infections have occurred. Instruct patients to seek medical attention if they show signs or symptoms of clinically significant chronic or acute infection. If a serious infection develops, discontinue Taltz until the infection resolves.
TB pre-treatment assessment
Assess patients for tuberculosis (TB) infection before starting treatment with Taltz. Do not administer to patients with active tuberculosis infection. Initiate treatment for latent tuberculosis before administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active tuberculosis during and after treatment.
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤ 0.1%), occurred in the Taltz group in clinical trials. Cases of anaphylaxis, including cases resulting in hospitalization, have been reported post-marketing with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate treatment.
Inflammatory bowel disease
Patients treated with Taltz may be at increased risk of inflammatory bowel disease. In clinical trials, Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a higher frequency in the Taltz group than in the placebo group. During treatment with Taltz, monitor patients for new onset or exacerbation of inflammatory bowel disease and, if IBD occurs, discontinue Taltz and initiate appropriate medical management.
Before starting treatment with Taltz, consider completing all age-appropriate vaccinations according to current vaccination guidelines. Avoid the use of live vaccines in patients treated with Taltz.
The most common (≥1%) adverse reactions associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and ringworm infections. Overall, the safety profiles observed in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondylitis and in pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic patients. arthritis and conjunctivitis, influenza and urticaria in pediatric psoriasis.
Please see the complete prescribing information and medication guide for Taltz. See the instructions for use supplied with the device.
IX HCP ISI 07MAY2020
Taltz® (ixekizumab) is a monoclonal antibody that selectively binds to the cytokine interleukin 17A (IL-17A) and inhibits its interaction with the IL-17 receptor. IL-17A is a natural cytokine involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.
About the Citrate-Free Injection Pain Study
The Citrate-Free Injection Pain Study (N=70) was a blinded, randomized crossover study in healthy participants aged 18-75 years to determine differences in injection site pain between the citrate-free formulation of Taltz and the original formulation of Taltz. The primary endpoint, pain intensity on injection, was measured by the visual analog scale (VAS) of pain from 0 to 100 mm.3
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Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) regarding Taltz as a treatment for people with moderate to severe plaque psoriasis, active psoriatic arthritis, active ankylosing spondylitis, and axial spondyloarthritis and other conditions and reflects Lilly’s current beliefs and expectations. However, as with any pharmaceutical product, there are considerable risks and uncertainties in the process of drug research, development and commercialization. Among other things, there can be no assurance that the results of future studies will be consistent with the results of studies to date. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, see Forms 10-K and 10-Q filed by Lilly with the Securities and Exchange Commission. the United States. Except as required by law, Lilly undertakes no obligation to update forward-looking statements to reflect events after the date of this release.
PP-IX-EN-5653 08/2022 © Lilly UNITED STATESLLC 2022. All rights reserved.
Taltz® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.
- Data on file. Lily UNITED STATES, LLC. DOF-IX-US-0310
- Data on file. Lily UNITED STATES, LLC. DOF-IX-US-0307
- Chabra S, Gill BJ, Gallo G, et al. Citrate-free formulation of ixekizumab: results of two clinical trials. Adv Ther. 2022;Epub (Incl Suppl Inf):1-11, 1-4. https://doi.org/10.1007/s12325-022-02126-0
SOURCEEli Lilly and company