Nemolizumab

AAD 2023: Late-Breaking Phase III Results Demonstrate nemolizumab’s Significant Impact on Prurigo Nodularis

Retrieved on: 
Saturday, March 18, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, Pharmacokinetics, American Academy, Associate, Prurigo, Skin, Patient, AAD, Itch, American Academy of Dermatology, Prurigo nodularis, Nemolizumab, III, Safety, Johns Hopkins School of Medicine, Pharmaceutical industry, Dermatology

Galderma has an extensive presence at the meeting with further updates from its broad portfolio across Therapeutic Dermatology, Dermatological Skincare and Injectable Aesthetics.

Key Points: 
  • Galderma has an extensive presence at the meeting with further updates from its broad portfolio across Therapeutic Dermatology, Dermatological Skincare and Injectable Aesthetics.
  • The phase III OLYMPIA 2 trial met all primary endpoints, showing nemolizumab monotherapy significantly improved pruritus (itch) and skin lesions compared with placebo in adult patients with moderate to severe prurigo nodularis.
  • “We are so pleased that we’re able to bring so much powerful new data to this year’s AAD congress.
  • Its continued commitment to delivering science and innovation across a highly differentiated portfolio is reflected in its extensive presence at AAD.

Galderma Delivers Strong H1 2022 Results and Continued Innovation Across Its Leading Dermatology Portfolio

Retrieved on: 
Thursday, August 25, 2022
Science, Biotechnology, Research, Pharmaceutical, Health, Cosmetics, Clinical Trials, Retail, COVID-19, Safety, IGA, Nemolizumab, Significance, Tretinoin, Science, Filler (animal food), International, Adult, Congress, Hyaluronic acid, Dermatology, Forte, Patient, City, Sale, Importance, Prurigo nodularis, Benzoyl peroxide, EBITDA, Skin, Projection, Aesthetics, Republican Political Alliance for Integrity and Reform, Acquisition, Growth, Galderma, Neuromodulation, Development, NYSE, Trihex, Heart, III, Perkinsus marinus, Environment, Pharmaceutical industry, Renewable energy

With its continued commitment to innovation and broad channel exposure, Galderma is well positioned to capitalize on this growing consumer demand.

Key Points: 
  • With its continued commitment to innovation and broad channel exposure, Galderma is well positioned to capitalize on this growing consumer demand.
  • In Injectable Aesthetics, Galderma continued to grow strongly in an environment of resilient consumer demand.
  • In Dermo-cosmetics, Galderma continued to outperform the market, with double-digit growth in eight out of the top 10 markets for the product category.
  • In Therapeutic Dermatology, Galderma navigated the anticipated annualization effect of the U.S. loss of exclusivity of Epiduo Forte and Soolantra with new launches.

Galderma Announces Positive Data From Phase III Trial, Demonstrating Efficacy and Safety of nemolizumab in Patients with Prurigo Nodularis

Retrieved on: 
Wednesday, June 22, 2022
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Itch, Adult, Patient, Pharmacokinetics, Nemolizumab, IGA, Prurigo nodularis, Quality of life, Safety, III, Prurigo, Pharmaceutical industry, Galderma

These phase III trial results indicate that nemolizumab has the potential to be a key therapeutic solution for patients suffering from moderate to severe prurigo nodularis.

Key Points: 
  • These phase III trial results indicate that nemolizumab has the potential to be a key therapeutic solution for patients suffering from moderate to severe prurigo nodularis.
  • OLYMPIA 2, part of the largest clinical program in prurigo nodularis to date aiming to recruit 540 patients, is a pivotal phase III clinical trial, evaluating the efficacy, safety, pharmacokinetics and immunogenicity of nemolizumab compared with placebo in adult patients with prurigo nodularis after a 16-week treatment period.
  • The results of OLYMPIA 2 provide further evidence that nemolizumab effectively improves skin lesions and pruritus in patients with prurigo nodularis.
  • A second phase III trial investigating the efficacy of nemolizumab in patients with prurigo nodularis, named OLYMPIA 1, is ongoing.

Galderma Announces New Data Demonstrating the Positive Anti-inflammatory Effect and Mode of Action of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis

Retrieved on: 
Monday, December 6, 2021
Health, Infectious Diseases, Clinical Trials, Research, Pharmaceutical, Science, Patient, Skin, Neuron, Prurigo nodularis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, IL-31, Breakthrough therapy, Genome, Partnership, Dermatology, Gene expression, Inflammation, Transcriptomics technologies, Bajaj Consumer Care, Systematic review, Itch, Atopic dermatitis, Extracellular matrix, The Journal of Allergy and Clinical Immunology, RNA, FDA, Journal, Disease, Nemolizumab, Food, Pharmaceutical industry, Medical device, Vaccine

Transcriptome data is an important step in validating the therapeutic effect of nemolizumab through a deeper understanding of the mode of action at a cellular level.

Key Points: 
  • Transcriptome data is an important step in validating the therapeutic effect of nemolizumab through a deeper understanding of the mode of action at a cellular level.
  • These data emphasize that nemolizumab may have a key role to play for patients with moderate to severe PN.
  • PN is a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated severe pruritus.
  • Nemolizumab, initially developed by Chugai Pharmaceutical Co., Ltd., was subsequently licensed to Galderma in 2016 worldwide except Japan and Taiwan.

Galderma Presents New Nemolizumab Data at EADV Reinforcing Rapid Onset of Action and Consistent Relief of Symptoms for People With Prurigo Nodularis and Atopic Dermatitis

Retrieved on: 
Wednesday, September 29, 2021
Other Consumer, Research, Biotechnology, Other Health, Health, Consumer, Pharmaceutical, Other Science, Science, Itch, Sleep, Clinical trial, PN, Patient, Prurigo nodularis, Congress, Atopic dermatitis, Nemolizumab, AD, Pharmaceutical industry

Results from two key trials of nemolizumab given every 4 weeks, demonstrate rapid onset of action and significant reduction in symptoms for patients with prurigo nodularis (PN) and atopic dermatitis (AD), and new real-world evidence highlight the PN disease burden.

Key Points: 
  • Results from two key trials of nemolizumab given every 4 weeks, demonstrate rapid onset of action and significant reduction in symptoms for patients with prurigo nodularis (PN) and atopic dermatitis (AD), and new real-world evidence highlight the PN disease burden.
  • "We are delighted to share new analyses and clinical trial data which reinforce nemolizumabs therapeutic potential and comprehensive benefits across prurigo nodularis and atopic dermatitis.
  • At study completion (12 weeks), over 50% of PN patients demonstrated a response to nemolizumab treatment (52.9% vs. 8.3%).
  • Nemolizumab, initially developed by Chugai Pharmaceutical Co., Ltd., was subsequently licensed to Galderma in 2016 worldwide except Japan and Taiwan.

Galderma Announces New England Journal of Medicine Publication from Phase 2 Study of Investigational Therapy Nemolizumab in Patients with Moderate to Severe Prurigo Nodularis

Retrieved on: 
Thursday, February 20, 2020
Biotechnology, Other Health, Health, General Health, Pharmaceutical, Other Science, Research, Infectious diseases, Genetics, Science, Clinical trials, Monoclonal antibodies, Prurigo nodularis, Medical specialties, Prurigo, Nemolizumab, Medicine, Clinical medicine, Nemolizumab, Galderma

Nemolizumab is a first-in-class investigational monoclonal antibody that blocks signaling of IL-31 that play a key role in the pathogenesis of PN.

Key Points: 
  • Nemolizumab is a first-in-class investigational monoclonal antibody that blocks signaling of IL-31 that play a key role in the pathogenesis of PN.
  • The Phase 2 study results indicate that nemolizumab may have a key role to play for patients with moderate to severe prurigo nodularis.
  • We are fully committed to test this drug further in Phase 3 studies and determined to bring solutions for patients suffering from prurigo nodularis.
  • Galderma is actively preparing for the initiation of a Phase 3 pivotal program with nemolizumab in adult patients with PN in 2020.

Galderma Investigational Therapy Nemolizumab Granted FDA Breakthrough Therapy Designation for the Treatment of Patients Suffering from Prurigo Nodularis

Retrieved on: 
Monday, December 9, 2019
Biotechnology, Pharmaceutical, Medical Supplies, General Health, Health, FDA, Medical devices, Clinical trials, Prurigo nodularis, Prurigo, the Breakthrough Therapy Designation, Nemolizumab, Galderma

Galderma today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational therapy nemolizumab for the treatment of pruritus associated with prurigo nodularis.

Key Points: 
  • Galderma today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational therapy nemolizumab for the treatment of pruritus associated with prurigo nodularis.
  • Prurigo nodularis is a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated severe pruritus.
  • We are very excited by the prospect of offering a treatment option to doctors, and their patients with prurigo nodularis, where currently there are no registered therapy options.
  • Galderma is now actively preparing for the initiation of a Phase 3 pivotal program with nemolizumab in adult patients with prurigo nodularis in 2020.

Galderma Advances Phase 3 Clinical Study with Nemolizumab in Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Thursday, October 10, 2019
Biotechnology, Health, Other Health, Pharmaceutical, Other Science, Research, General Health, Genetics, Science, Clinical trials, Medical specialties, Immunology, Monoclonal antibodies, RTT, Type I hypersensitivity, Drugs, Atopic dermatitis, Dermatitis, Nemolizumab, Atopy, Dupilumab, Tralokinumab

This study is a randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of nemolizumab in subjects with moderate-to-severe atopic dermatitis.

Key Points: 
  • This study is a randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of nemolizumab in subjects with moderate-to-severe atopic dermatitis.
  • Nemolizumab is a first-in-class investigational monoclonal antibody that blocks signaling of IL-31, a cytokine that plays a key role in the pathogenesis of moderate-to-severe atopic dermatitis.
  • The Phase 2 results showed clear clinical benefits, adding to the growing scientific evidence that the IL-31 pathway may be an important driver in atopic dermatitis.
  • Silverberg JI, et al., Phase 2b Randomized Study of Nemolizumab in Adults with Moderate-Severe Atopic Dermatitis and Severe Pruritus, Journal of Allergy and Clinical Immunology 2019, doi: https://doi.org/10.1016/j.jaci.2019.08.013 .

Galderma Presented Final Results from Phase 2b Study of Nemolizumab in Patients with Moderate-to-Severe Atopic Dermatitis at the 2019 American Academy of Dermatology Annual Meeting Late-Breaking Session

Retrieved on: 
Friday, March 8, 2019
Health, Clinical trials, Infectious diseases, Pharmaceutical, Other Health, Research, Medical Supplies, Science, General Health, Managed care, Medical specialties, Steroids, Immunology, Corticosteroids, RTT, Type I hypersensitivity, Monoclonal antibodies, Immunosuppressants, Atopic dermatitis, Dermatitis, Nemolizumab, Atopy

Galderma, Nestl Skin Healths medical solutions business, presented the final results from a Phase 2b dose-ranging study of nemolizumab, an investigational therapy in adult patients with moderate-to-severe atopic dermatitis (AD), at the late-breaking session of the 2019 American Academy of Dermatology annual meeting (March 1-5).

Key Points: 
  • Galderma, Nestl Skin Healths medical solutions business, presented the final results from a Phase 2b dose-ranging study of nemolizumab, an investigational therapy in adult patients with moderate-to-severe atopic dermatitis (AD), at the late-breaking session of the 2019 American Academy of Dermatology annual meeting (March 1-5).
  • This double blind, placebo-controlled, 24 week, dose-ranging Phase 2b study enrolled 226 subjects with moderate-to-severe AD not adequately controlled with topical corticosteroids.
  • A 73 percent reduction in mean EASI score was observed at Week 24 with nemolizumab compared with 58 percent for placebo.
  • The results of this Phase 2b study showed that nemolizumab significantly improved atopic dermatitis signs and very rapidly improved atopic dermatitis symptoms, including pruritus and sleep disturbance.