Tralokinumab

Data from Brainomix's Collaboration with AstraZeneca Shows its AI-Powered e-Lung Better Identifies Lung Fibrosis Patients at Risk of Decline

Retrieved on: 
Wednesday, March 27, 2024
AJRCCM, Medical research, ILD, AstraZeneca, ATS, Survival, Data science, Critical Care Medicine (journal), Partnership, Risk, Boehringer Ingelheim, Royal Brompton Hospital, Patient, American Journal, Lung, WRVS, Biopharmaceutical, Biomarker, Vital capacity, American Thoracic Society, Idiopathic pulmonary fibrosis, IPF, Clinical trial, Tralokinumab, Idiopathic disease, FVC

The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).

Key Points: 
  • The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).
  • The patient data from the trial was processed with Brainomix's e-Lung tool.
  • The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
  • WRVS was also able to predict both short- and long-term outcomes of the patients, including lung function decline and survival.

Data from Brainomix's Collaboration with AstraZeneca Shows its AI-Powered e-Lung Better Identifies Lung Fibrosis Patients at Risk of Decline

Retrieved on: 
Wednesday, March 27, 2024
AJRCCM, Medical research, ILD, AstraZeneca, ATS, Survival, Data science, Critical Care Medicine (journal), Partnership, Risk, Boehringer Ingelheim, Royal Brompton Hospital, Patient, American Journal, Lung, WRVS, Biopharmaceutical, Biomarker, Vital capacity, American Thoracic Society, Idiopathic pulmonary fibrosis, IPF, Clinical trial, Tralokinumab, Idiopathic disease, FVC

The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).

Key Points: 
  • The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).
  • The patient data from the trial was processed with Brainomix's e-Lung tool.
  • The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
  • WRVS was also able to predict both short- and long-term outcomes of the patients, including lung function decline and survival.

LEO Pharma Inc. Announces U.S. FDA approval of Adbry® (tralokinumab-ldrm) for the Treatment of Moderate-to-severe Atopic Dermatitis in Pediatric Patients Aged 12-17 Years

Retrieved on: 
Friday, December 15, 2023
FDA, Health, Consumer, Teens, Pharmaceutical, Biotechnology, Adolescence, Lower respiratory tract infection, Safety, Food, Ageing, Incidence, IGA, Disease, Clinical trial, Patient, NRS, Conjunctivitis, EVP, Atopic dermatitis, LEO, Diagnosis, Skin, Leo Pharma, Pharmaceutical industry, Nursing, Generic drug, Tralokinumab, Northwestern University

This critical patient group now has access to a much-needed additional treatment option to manage their atopic dermatitis," said Brian Hilberdink, EVP and President, Region North America, LEO Pharma, “We are delighted to be able to offer Adbry, a highly targeted treatment, to both adult and pediatric patients in the U.S.

Key Points: 
  • This critical patient group now has access to a much-needed additional treatment option to manage their atopic dermatitis," said Brian Hilberdink, EVP and President, Region North America, LEO Pharma, “We are delighted to be able to offer Adbry, a highly targeted treatment, to both adult and pediatric patients in the U.S.
  • *1
    The approval is based on data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adbry in 289 pediatric patients aged 12-17 years with moderate-to-severe AD who were candidates for systemic therapy.
  • A total of 98 patients received an initial dose of Adbry 300 mg followed by 150 mg every other week up to Week 16.
  • “Such advances in the atopic dermatitis treatment landscape provide much-needed hope for pediatric patients seeking a long-term treatment option that could work for them.”
    Dr. Paller is an ECZTRA 6 clinical trial investigator and a paid consultant of LEO Pharma Inc.

LEO Pharma Presents Adbry® (tralokinumab-ldrm) Data at 2023 Fall Clinical Dermatology Conference

Retrieved on: 
Friday, October 20, 2023
Biotechnology, Pharmaceutical, Health, Janus, Tralokinumab, Patient, Adolescence, AD, Ageing, Catalog, Leo Pharma, Conference, Systematic review, Research, RWE, Meta-analysis, TRACE, Various, Disease, S. aureus, Safety, Atopic dermatitis, LEO, Pharmaceutical industry, Vaccine

LEO Pharma A/S, a global leader in medical dermatology, will present a catalog of new clinical and real-world data around tralokinumab-ldrm in the treatment of moderate-to-severe atopic dermatitis (AD).

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, will present a catalog of new clinical and real-world data around tralokinumab-ldrm in the treatment of moderate-to-severe atopic dermatitis (AD).
  • The drug is marketed in the U.S. as Adbry® for adult patients (aged 18+ years) with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
  • The findings are being presented across 12 posters at the 2023 Fall Clinical Dermatology Conference taking place in Las Vegas, Nevada, from October 19-22, 2023.1-12
    “We are thrilled to present such a wealth of tralokinumab-ldrm data, which will further develop our understanding of how to meet the needs of patients living with atopic dermatitis,” says Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma.
  • “The breadth and depth of LEO Pharma data being presented at the Fall Clinical Dermatology Conference this year will showcase our leadership in the medical dermatology space and our continued commitment to the whole patient community.

LEO Pharma Presents New Long-Term Data on Use of Adtralza® (tralokinumab) to Treat Moderate-to-Severe Atopic Dermatitis (AD)

Retrieved on: 
Friday, October 13, 2023
Health, Science, Pharmaceutical, Research, Clinical Trials, Congress, European Academy of Occupational Health Psychology, TRACE, Aes, Internal Coordinate Mechanics, Atopic dermatitis, Safety, Eczema Area and Severity Index, LEO, Pneumonia severity index, IGA, AD, ICI, Leo Pharma, Patient, Poster, Pharmaceutical industry, Dermatology, Venereology, Tralokinumab

LEO Pharma A/S, a global leader in medical dermatology, today presented new data assessing the long-term safety and efficacy data of continuous treatment with Adtralza® (tralokinumab) over four years for moderate-to-severe atopic dermatitis (AD) in adults.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today presented new data assessing the long-term safety and efficacy data of continuous treatment with Adtralza® (tralokinumab) over four years for moderate-to-severe atopic dermatitis (AD) in adults.
  • The analysis was of participants from ECZTEND who had previously enrolled in the ECZTRA 1 and 2 phase 3 trials.
  • Again, the pattern of adverse events (AEs) was consistent with the initial placebo-controlled treatment period and with no new safety signals identified.
  • “We aim to use this long-term and real-world evidence to build upon Adtralza’s existing foundation of research.”

LEO Pharma Receives Positive CHMP Opinion for New Adtralza® (tralokinumab) Injection Device

Retrieved on: 
Friday, June 23, 2023
Biotechnology, Pharmaceutical, Health, Medical Devices, Injection, Partnership, Leo Pharma, Civil service commission, European Medicines Agency, European Directive on Traditional Herbal Medicinal Products, Committee, EMA, United Arab Emirates, European Commission, Patient, LEO, European, Adolescence, Tralokinumab, Committee for Medicinal Products for Human Use, AD, EC, Caregiver, CHMP, Vaccine, Pharmaceutical industry, EU

LEO Pharma A/S, has today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion that recommends the approval of Adtralza® (tralokinumab) solution for injection in a new single dose (300 mg) 2 ml pre-filled pen.

Key Points: 
  • LEO Pharma A/S, has today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion that recommends the approval of Adtralza® (tralokinumab) solution for injection in a new single dose (300 mg) 2 ml pre-filled pen.
  • Adtralza, a high-affinity fully human monoclonal antibody,1 has previously been available in a 1 ml pre-filled syringe.
  • For patients who prefer the pre-filled syringe, this administration option will continue to be available in markets where Adtralza is already launched.
  • In the U.S., Adtralza is marketed under the tradename Adbry® and is approved for use in adults with moderate to severe AD.

ASLAN Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, April 28, 2023
Abstract, Purchasing, Partnership, Executive director, Leo Pharma, Marketing, ISID, ASLN, ADS, TMO, Atopic dermatitis, Thermo Fisher Scientific, Neck, Associate, HCP, Sale, Yale School of Medicine, Alopecia areata, Development, Paul Khavari, Type 2, Journal, MD, Patient, Investment, International Society for Infectious Diseases, SAN, Autoimmune disease, Sanofi, Power purchase agreement, IL4R, Tralokinumab, Research, AD, NYSE, Safety, Pharmaceutical industry, Cryptocurrency, Video game, Head, Dermatology, AA

“We have also advanced farudodstat into a Phase 2a, proof-of-concept study in alopecia areata (AA) expected to commence enrollment in the second quarter of 2023.

Key Points: 
  • “We have also advanced farudodstat into a Phase 2a, proof-of-concept study in alopecia areata (AA) expected to commence enrollment in the second quarter of 2023.
  • The trial will recruit around 60 AA patients in the US and enrollment is expected to begin in the second quarter of 2023.
  • Research and development expenses were $14.1 million in the first quarter of 2023 compared to $9.4 million in the first quarter of 2022.
  • General and administrative expenses were $4.0 million in the first quarter of 2023 compared to $2.5 million in the first quarter of 2022.

University of Connecticut Takes First Place in AMCP Foundation Case Study Competition for Future Pharmacists

Retrieved on: 
Friday, April 7, 2023
University of Florida College of Pharmacy, CT, CAE, University, University of Minnesota College of Pharmacy, Florida College, Doctor of Pharmacy, AMCP, Health equity, Roche, Atopic dermatitis, MBA, Executive sponsor, Genentech, P&T, Competition, School, Pharmacist, Patient, Tralokinumab, Disease, Pharmaceutical industry, Pharmacy

First Place: University of Connecticut School of Pharmacy, Storrs, CT

Key Points: 
  • First Place: University of Connecticut School of Pharmacy, Storrs, CT
    Second Place: University of Washington School of Pharmacy, Seattle, WA
    Third Place: University of Minnesota College of Pharmacy, Minneapolis, MN
    Additionally, University of Southern California School of Pharmacy, and University of Florida College of Pharmacy competed in the live national finals.
  • Student pharmacists reviewed the drug dossier in the AMCP Format for Formulary Submissions and presented to a mock P&T Committee.
  • "This competition is the marquee event for student pharmacists who are interested in managed care," said AMCP Foundation executive director Paula J. Eichenbrenner, MBA, CAE.
  • AMCP Foundation thanks LEO Pharma Inc., for use of the Adbry dossier for this competition and FormularyDecisions for hosting AMCP eDossiers.

LEO Pharma Presents New Adbry™ (tralokinumab-ldrm) Data in Adolescent Population from ECZTRA 6 and ECZTEND Trials at AAD 2023 Annual Meeting

Retrieved on: 
Friday, March 17, 2023
Pharmaceutical, Health, Clinical Trials, Keratitis, American Academy of Dermatology, University, Paced Auditory Serial Addition Test, Leo Pharma, S. aureus, Week, Dermatitis, Infection, Food, Aes, American Academy, Atopic dermatitis, Skin, Gene expression, Staphylococcus, Staphylococcus aureus, Malignancy, Patient, AAD, Lower respiratory tract infection, LEO, Annual general meeting, European, Adolescence, PYE, University of Rochester Medical Center, Keratoconjunctivitis, Ageing, AD, FDA, Conjunctivitis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gene, Safety, Pharmaceutical industry, Medical imaging, Vaccine, Tralokinumab

The data was presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting.

Key Points: 
  • The data was presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting.
  • S. aureus is consistently found in the skin lesions of patients with AD and contributes to skin irritation and infections.
  • “In addition, the latest analysis of data from adolescents in the ECZTEND study shows the long-term safety and efficacy profile of Adbry.
  • Adtralza is approved for use in adults with moderate-to-severe AD in the U.S., United Arab Emirates, Switzerland, and Japan.

Japan Ministry of Health, Labor and Welfare Approves Manufacturing and Marketing of Adtralza® (tralokinumab) in Japan for Adults with Atopic Dermatitis

Retrieved on: 
Friday, December 23, 2022
Biotechnology, Pharmaceutical, Health, Dermatology, Leo Pharma, Patient, Investment, MHLW, LEO, National Association Medical Staff Services, Atopic dermatitis, Marketing, Pharmaceutical industry, Health, Tralokinumab

LEO Pharma A/S, a global leader in medical dermatology, announced today that the Japan Ministry of Health, Labor and Welfare (MHLW) has granted approval for the manufacturing and marketing of Adtralza® (tralokinumab) subcutaneous injection (S.C.) for adults with atopic dermatitis, which has inadequately responded to conventional therapies.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, announced today that the Japan Ministry of Health, Labor and Welfare (MHLW) has granted approval for the manufacturing and marketing of Adtralza® (tralokinumab) subcutaneous injection (S.C.) for adults with atopic dermatitis, which has inadequately responded to conventional therapies.
  • “Today’s approval is a significant advancement for those patients in Japan who continue to suffer from the often-debilitating symptoms of atopic dermatitis and are in need of a new treatment option to manage their chronic condition,” said Kook Hyun Son, General Manager of LEO Pharma K.K.
  • “The Japan approval is a demonstration of our strategy to expand the availability of Adtralza to millions of patients around the world who are faced with the daily challenges of living with chronic and often debilitating symptoms of atopic dermatitis,” said Becki Morison, executive vice president of global strategy and international operations, LEO Pharma A/S.
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