Breaking News
July 22, 2018 - Frequency of joint replacements halved in rheumatoid arthritis patients between 1997-2010
July 22, 2018 - QUT researcher highlights growing impact of non-prescription antibiotics supply in pharmacies
July 22, 2018 - UK health communication researcher seeks solutions for disposing leftover medicine
July 22, 2018 - Pfizer Initiates Pivotal Phase 3 Program for Investigational Hemophilia B Gene Therapy Fidanacogene Elaparvovec
July 22, 2018 - Mutation discovered to protect against Alzheimer’s disease in mice
July 22, 2018 - Researchers reveal how patients in urban areas develop multiple, long-term conditions
July 22, 2018 - Replacing conventional cancer treatment with complementary therapy linked to increased risk of death
July 22, 2018 - Study uncovers molecular key for delaying progression of multiple sclerosis
July 22, 2018 - Availability of athletic trainer in high school reduces injury rates in girls’ sports, shows study
July 22, 2018 - FDA Approves Krintafel (tafenoquine) for the Radical Cure of Plasmodium vivax Malaria
July 22, 2018 - Novel nuclear medicine probe will help assess new drugs for neurodegenerative diseases
July 22, 2018 - Physical activity even during exposure to air pollution can reduce risk of heart attack
July 22, 2018 - Scientists discover protein regulator of myelin production
July 22, 2018 - Sleep disturbances associated with higher dementia risk
July 22, 2018 - Scientists move one step further in developing eye drops to treat age-related macular degeneration
July 22, 2018 - Five-Year Stroke Rates Lower After PCI Versus CABG
July 21, 2018 - Alopecia areata – Genetics Home Reference
July 21, 2018 - Study identifies overdose risk factors in youth with substance use disorders
July 21, 2018 - Drug in clinical trials for Parkinson’s disease offers hope for treating heart failure
July 21, 2018 - Coupling free malaria tests with diagnosis-dependent vouchers can improve rational use of ACTs
July 21, 2018 - Sweetness depends on molecular interactions between specific sugars and water in saliva
July 21, 2018 - Muscle fitness is strongly associated with improved rate of ageing in the brain
July 21, 2018 - Resetting E-Prescriptions for Opioids Helps Curb Use: Study
July 21, 2018 - Overuse of antibiotics not what the doctor ordered
July 21, 2018 - Bundled-payment system did not lower costs for serious medical conditions, shows study
July 21, 2018 - Therapy dogs found to be effective in reducing ADHD symptoms in children
July 21, 2018 - Could rotating multiple therapists better treat PTSD patients?
July 21, 2018 - Binge drinking impairs working memory in adolescent brain
July 21, 2018 - Dying at home could be beneficial for terminally ill cancer patients and their relatives
July 21, 2018 - Researchers identify subtypes of retinal ganglion cells using single-cell RNA sequencing
July 21, 2018 - Study uncovers opportunities to reduce death by suicide among cancer patients
July 21, 2018 - Genetic sequencing reveals new clues to aggressiveness of prostate cancer
July 21, 2018 - BioSight Launches a Phase 2b Clinical Trial of BST-236 as a First-Line Treatment of Acute Myeloid Leukemia
July 21, 2018 - First major study comparing robotic to open surgery published in The Lancet
July 21, 2018 - ADHD medications may fail to improve cognition in healthy college students, study shows
July 21, 2018 - Intervention program that includes a personalized app could benefit teens with suicidal thoughts
July 21, 2018 - Researchers identify new compound that protects against neurodegeneration
July 21, 2018 - Gene therapy may hold potential to treat people with spinal cord injuries
July 21, 2018 - FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen
July 21, 2018 - Surgeons have substantial impact on genetic testing in breast cancer patients who need it
July 21, 2018 - Species diversity can have positive and negative impacts on disease transmission
July 21, 2018 - Genome research suggests presence of enteric fever in medieval Europe
July 21, 2018 - Risk of Sensory Deficits Drops With Rising Gestational Age
July 21, 2018 - Mum’s sleep matters—the effect of sleep on an unborn baby
July 21, 2018 - UC San Diego researchers awarded two grants for investigating stem cell-based therapies
July 21, 2018 - Cellular ‘garbage disposal’ may actually work on some of the proteins to neuronal development
July 21, 2018 - More Pregnant Women Having Heart Attacks
July 21, 2018 - Acne Breakouts | NIH News in Health
July 21, 2018 - Change health messaging to focus on potential impact to help stop the next pandemic
July 21, 2018 - Frailty associated with poor survival rates in young heart patients
July 21, 2018 - New discovery could save millions of lives from fatal fungal infections
July 21, 2018 - OBD presents latest data on the use of EpiSwitch™ in predicting patient response to immunotherapy and identifying lymphoma subtypes
July 21, 2018 - Childhood adversity increases susceptibility to addiction via immune response
July 21, 2018 - Scientists identify potential target for the treatment of binge eating
July 21, 2018 - Whole-brain LIPUS therapy improves cognitive dysfunction in mice simulating dementia, Alzheimer’s
July 21, 2018 - Digital media use raising risk of ADHD symptoms among the young
July 21, 2018 - Phase 3 study of tanezumab in patients with osteoarthritis pain meets all three co-primary endpoints
July 21, 2018 - Restoring mitochondrial function to reverse aging-related skin wrinkles, hair loss in mice
July 21, 2018 - SP PennTech introduces RW-500 rotary vial washer for biotech, pharmaceutical applications
July 21, 2018 - Researchers to study molecular mechanisms behind susceptibility of males to autism
July 21, 2018 - Using tendon transfer surgery to restore key functions in spinal cord injury patient
July 21, 2018 - Scientists create wearable device that measures cortisol in sweat
July 21, 2018 - Researchers study efficacy and safety of new treatment for OUD
July 21, 2018 - Fourth Published Clinical Trial Confirms Long-Term Safety of Niagen Supplementation at High Doses and Shows Potential for Improvement in Liver Health
July 21, 2018 - Study examines effects of a two-day intermittent calorie restriction diet for patients with type 2 diabetes
July 21, 2018 - Greening vacant urban land reduces feelings of depression for surrounding residents
July 21, 2018 - Parents say intense gun violence in PG-13 movies appropriate for teens 15 and older
July 21, 2018 - Collaborative study to assess effects of exercise training for cognitive deficits in MS
July 21, 2018 - FAU researchers find possible cause of Parkinson’s disease in the patients’ immune system
July 21, 2018 - Protective qualities of ‘good cholesterol’ reduce after menopause
July 21, 2018 - Researchers develop new way to uncover hidden breast cancer tumors
July 21, 2018 - FDA approves first drug for treatment of adult AML patients with specific genetic mutation
July 21, 2018 - Top AI companies join hands to discover novel drugs for DMD
July 21, 2018 - Ferring announces FDA approval of ZOMACTON for injection in four new pediatric indications
July 20, 2018 - Researchers design proteins that can self-assemble into complex structures
July 20, 2018 - AVITA Medical expands management team to support launch of RECELL device to treat burns
July 20, 2018 - FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation
July 20, 2018 - Developmental screening and surveillance rates remain low, new study suggests
July 20, 2018 - TGen opens tissue donation portal to advance DIPG research
July 20, 2018 - Health impact of highly processed summertime staples
Lilly’s Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Active Psoriatic Arthritis

Lilly’s Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Active Psoriatic Arthritis

image_pdfDownload PDFimage_print

INDIANAPOLIS, Dec. 1, 2017 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis (PsA).1 Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.1

“PsA is a chronic, progressive and painful form of inflammatory arthritis that impacts approximately 1.6 million Americans living with the disease,” said Christi Shaw, president, Lilly Bio-Medicines. “We are proud to offer a new treatment option that can provide improvements in joint symptoms for these patients, further demonstrating Lilly’s overall commitment to immunology.”

Taltz may be administered alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate.1 Taltz should not be used in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.1 Taltz may increase the risk of infection.1 Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations.1

The efficacy and safety of Taltz was determined from findings from two randomized, double-blind, placebo-controlled Phase 3 studies – SPIRIT-P1 and SPIRIT-P2 – which included more than 670 adult patients with active PsA.1 SPIRIT-P1 evaluated the safety and efficacy of Taltz compared to placebo in patients with active PsA who had never been treated with a biologic disease-modifying antirheumatic drug.1 SPIRIT-P2 evaluated the safety and efficacy of Taltz compared to placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors.1 Across both studies, patients were required to have a diagnosis of active PsA for at least six months and at least three tender and three swollen joints.1 Non-responder imputation (NRI) methods were used. Inadequate responders (defined by blinded tender and swollen joint count criteria) at Week 16 received rescue therapy and were analyzed as non-responders.1

In studies of biologic-naïve and TNFi-experienced patients, the primary efficacy endpoint was the proportion of patients at 24 weeks achieving ACR20 response, which represents a 20 percent reduction in a composite measure of disease activity as defined by the American College of Rheumatology (ACR).1 Results from both studies demonstrated that patients treated with Taltz achieved significant improvement in joint symptoms, as measured by ACR20, compared with placebo.1 At 24 weeks, patients achieved ACR20 at the following response rates:

  • SPIRIT-P1: 58 percent of patients treated with Taltz vs. 30 percent for placebo1
  • SPIRIT-P2: 53 percent of patients treated with Taltz vs. 20 percent for placebo1

“For patients with PsA, treatment goals often include improvement in joint symptoms,” said Philip Mease, M.D., Swedish Medical Center and University of Washington. “Based on the study results, Taltz can provide significant improvement in joint symptoms for patients who had never been treated with a biologic disease-modifying antirheumatic drug as well as patients who had inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors.”

Lilly will work with insurers, health systems and providers to ensure patients are able to access this treatment. Patients, physicians, pharmacists or other healthcare professionals with questions about Taltz should contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) or visit www.lilly.com.

Indications and Usage

Taltz is approved for the treatment of adults with active psoriatic arthritis.1 Taltz is also approved to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.1

About Taltz

Taltz (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.1 IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.1 Taltz inhibits the release of pro-inflammatory cytokines and chemokines.1

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab) as a treatment for moderate-to-severe plaque psoriasis and active psoriatic arthritis, and reflects Lilly’s current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that Taltz will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

1 Taltz Prescribing Information, 2017.
2 Ritchlin C, et. al. Psoriatic Arthritis. New England Journal of Medicine. 2017;376:957-70.

SOURCE Eli Lilly and Company

Posted: December 2017

Related Articles:

Taltz (ixekizumab) FDA Approval History

Tagged with:

About author

Related Articles