Nemolizumab

Galderma @ AAD 2024: New Data Demonstrate the Long-Term Efficacy of Nemolizumab in Prurigo Nodularis and Its Durability in Atopic Dermatitis

Retrieved on: 
Sunday, March 10, 2024
Health, Medical Devices, Other Health, Clinical Trials, Research, Science, Biotechnology, Dermatology Life Quality Index, Atopic dermatitis, Prurigo nodularis, Nemolizumab, Patient, Sleep, American Academy, Quality of life, European Medicines Agency, Skin, AAD, FDA, DLQI, IGA, Food, Pharmaceutical industry

Galderma today announced new data demonstrating nemolizumab’s long-term and increasing efficacy on skin lesions and other symptoms in prurigo nodularis through to week 52 in the OLYMPIA LTE study.1 Additionally, data from the ARCADIA 1 and 2 trials in atopic dermatitis indicate that the majority of patients maintained skin and itch responses through to week 48, with similar efficacy observed whether receiving nemolizumab every four (Q4W) or eight weeks (Q8W).2 These late-breaking data are being presented today at the 2024 American Academy of Dermatology Association (AAD) Annual Meeting, taking place on March 8-12, 2024.

Key Points: 
  • Galderma today announced new data demonstrating nemolizumab’s long-term and increasing efficacy on skin lesions and other symptoms in prurigo nodularis through to week 52 in the OLYMPIA LTE study.1 Additionally, data from the ARCADIA 1 and 2 trials in atopic dermatitis indicate that the majority of patients maintained skin and itch responses through to week 48, with similar efficacy observed whether receiving nemolizumab every four (Q4W) or eight weeks (Q8W).2 These late-breaking data are being presented today at the 2024 American Academy of Dermatology Association (AAD) Annual Meeting, taking place on March 8-12, 2024.
    build and strengthen for these debilitating diseases, where symptoms
    such as intense itch can put a significant burden on quality of life.
  • response in prurigo nodularis and atopic dermatitis, respectively.”
    69% of those who had received continuous nemolizumab treatment and 65% of nemolizumab-naïve patients had reached clearance or almost-clearance of skin lesions, as measured on the Investigator’s Global Assessment (IGA) score
    Sleep disturbance, as measured by the sleep disturbance numerical rating scale (SD-NRS), also continued to improve, as well as quality of life, as measured by the Dermatology Life Quality Index (DLQI).1
    Results also reinforced nemolizumab’s rapid onset of action, with nemolizumab-naïve patients rapidly achieving an at least four-point improvement in itch intensity, as measured by the PP-NRS, as early as week four, consistent with the continuous-nemolizumab cohort.
  • Nemolizumab was also granted U.S. FDA Priority Review for prurigo nodularis.
  • Further submissions to regulatory authorities in additional countries are planned in 2024.

Galderma to Showcase Latest Updates From Its Broad, Innovative and Leading Dermatology Portfolio at the 2024 American Academy of Dermatology Annual Meeting

Retrieved on: 
Wednesday, February 28, 2024
Research, Clinical Trials, Biotechnology, Managed Care, Health, Cosmetics, Pharmaceutical, Retail, Science, Acne, Nemolizumab, Pacific Ocean, Atopic dermatitis, Prurigo nodularis, Hyperhidrosis, Dermatology, Skin, Consultant, AAD, Marriott Marquis, Safety, Patient, Itch, START, American Academy, Medical device

Galderma, the pure-play dermatology category leader, will be showcasing its latest clinical and educational efforts at the American Academy of Dermatology (AAD) Annual Meeting from March 8-12, 2024, highlighting its broad, innovative and leading dermatology portfolio.

Key Points: 
  • Galderma, the pure-play dermatology category leader, will be showcasing its latest clinical and educational efforts at the American Academy of Dermatology (AAD) Annual Meeting from March 8-12, 2024, highlighting its broad, innovative and leading dermatology portfolio.
  • “Our vast presence at AAD combines new data, novel educational activities and patient perspectives, demonstrating how we are putting our commitment to addressing the needs of the dermatology community into action.
  • The event is taking place on Saturday, March 9, in the Pacific Ballroom 21-26, Marriott Marquis San Diego Marina, from 7:00 to 9:00 PM PST.
  • *All presenters are paid consultants or employees of Galderma.

Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in the U.S. and EU

Retrieved on: 
Wednesday, February 14, 2024
Lifestyle, Biotechnology, FDA, Health, Pharmaceutical, Cosmetics, Research, Retail, Consumer, Science, Clinical Trials, Nemolizumab, Quality of life, Atopic dermatitis, Food, Prurigo nodularis, File, Safety, Prurigo, European Medicines Agency, Sleep, Patient, Diagnosis, Breakthrough therapy, Itch, Priority review

This follows its designation as a Breakthrough Therapy for the treatment of pruritus associated with prurigo nodularis, originally granted in December 2019 and reconfirmed in March 2023.

Key Points: 
  • This follows its designation as a Breakthrough Therapy for the treatment of pruritus associated with prurigo nodularis, originally granted in December 2019 and reconfirmed in March 2023.
  • Priority Review is granted for medicines that would significantly improve the treatment, diagnosis or prevention of serious conditions.
  • The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab in both prurigo nodularis and atopic dermatitis.
  • “The relentless itch experienced by many people living with prurigo nodularis and atopic dermatitis has a significant impact on their overall quality of life.

Galderma Reports Record Net Sales of Over 3 B USD for the First Nine Months of 2023 With Strong Growth Momentum Across All Product Categories

Retrieved on: 
Tuesday, November 21, 2023
Cosmetics, Retail, Health, Technology, Health Technology, Artificial Intelligence, Pharmaceutical, Itch, PIH, Prurigo nodularis, Investment, International Chamber of Commerce, Patient, FACE, R, Growth, IIB, Food, International, Patient satisfaction, Commerce, Calcineurin, Science, Sculptra, Atopic dermatitis, Galderma, Neuromodulation, Adapalene, Botulinum toxin, EBITDA, Adolescence, Risk, ICC, Ivermectin, Partnership, Symantec Endpoint Protection, Ipsen, Skin, PN, Nemolizumab, Liquid Lives, Cryptocurrency, Pharmaceutical industry, Dermatology, Cetaphil

For the period, net sales growth was strong across all product categories, with balanced contributions across volume, pricing and brand mix.

Key Points: 
  • For the period, net sales growth was strong across all product categories, with balanced contributions across volume, pricing and brand mix.
  • Internationally, there was particularly strong growth momentum across product categories in fast growing Asian and Latin American markets, including China, India, and Mexico.
  • Based on the strong performance so far, Galderma is on track to deliver at the upper end of its 6-9% net sales constant currency growth range.
  • In Dermatological Skincare, Galderma experienced double-digit net sales growth year-on-year over the first nine months of 2023 on a constant currency basis.

Galderma Phase III Data Published in the New England Journal of Medicine: Full OLYMPIA 2 Trial Results Demonstrate Nemolizumab’s Rapid Onset of Action in Prurigo Nodularis Patients

Retrieved on: 
Thursday, October 26, 2023
Health, Managed Care, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Prurigo, Nemolizumab, Safety, Prurigo nodularis, Clinical trial, Patient, III, The New England Journal of Medicine, Multimedia, Pharmaceutical industry, Galderma, Medicine

Galderma today announced that the New England Journal of Medicine has published full results from the phase III OLYMPIA 2 trial evaluating the efficacy and safety of nemolizumab monotherapy in adults with prurigo nodularis.

Key Points: 
  • Galderma today announced that the New England Journal of Medicine has published full results from the phase III OLYMPIA 2 trial evaluating the efficacy and safety of nemolizumab monotherapy in adults with prurigo nodularis.
  • Nemolizumab was well tolerated, and its safety profile was consistent with phase II trial results.1
    This press release features multimedia.
  • Results from the phase III OLYMPIA 2 trial will be submitted to selected health authorities around the world.
  • To learn more about prurigo nodularis, watch this video from the New England Journal of Medicine.

Galderma @ EADV 2023: Phase III Trials Demonstrate Nemolizumab’s Efficacy and Rapid Onset of Action in Atopic Dermatitis and Prurigo Nodularis

Retrieved on: 
Wednesday, October 11, 2023
Health, Managed Care, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, III, Multimedia, Journal of the European Academy of Dermatology and Venereology, Galderma, Atopic dermatitis, Prurigo nodularis, Mental health, Congress, Itch, Nemolizumab, Adolescence, IGA, Sleep, Skin, Plasma protein binding, Patient, Pharmaceutical industry, Dermatology, Venereology

Galderma announced positive data from three pivotal phase III trials in atopic dermatitis and prurigo nodularis – ARCADIA 1 and 2 and OLYMPIA 1, respectively.

Key Points: 
  • Galderma announced positive data from three pivotal phase III trials in atopic dermatitis and prurigo nodularis – ARCADIA 1 and 2 and OLYMPIA 1, respectively.
  • The late-breaking data were presented today at the 2023 European Academy of Dermatology and Venereology (EADV) congress in Berlin.
  • View the full release here: https://www.businesswire.com/news/home/20231011848851/en/
    “While atopic dermatitis and prurigo nodularis are distinct diseases, their commonality lies in the severe, persistent itch, which leads to poor quality sleep and negatively impacts mental health.
  • Statistically significant results at week 16 and earlier time points also show nemolizumab’s rapid onset of action on itch and sleep disturbance.

EADV 2023: Galderma to Present New Data Showcasing Its Continued Leadership in Dermatology

Retrieved on: 
Wednesday, October 4, 2023
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Sleep, Acne, Atopic dermatitis, Prurigo, Journal of the European Academy of Dermatology and Venereology, Patient, Physician, Hall, Adolescence, Knowledge, Prurigo nodularis, Itch, Congress, Nemolizumab, III, ARCADIA, Safety, Pharmaceutical industry, Galderma, Dermatology, Venereology

Galderma, the emerging pure-play dermatology category leader, announced today it will be showcasing updates from across its broad and innovative dermatology portfolio at the 32nd European Academy of Dermatology and Venereology (EADV) congress in Berlin, October 11-14, 2023.

Key Points: 
  • Galderma, the emerging pure-play dermatology category leader, announced today it will be showcasing updates from across its broad and innovative dermatology portfolio at the 32nd European Academy of Dermatology and Venereology (EADV) congress in Berlin, October 11-14, 2023.
  • For more than 40 years, Galderma has focused exclusively on delivering advances in dermatology, and its extensive presence at this year’s congress underlines the true impact of its industry-leading expertise and ongoing commitment to cutting-edge science, brands and services.
  • “We’re so excited to share such an extensive range of new data at EADV this year, and for another opportunity to engage with the community of physicians attending.
  • Results from the phase IV START study reinforce Galderma’s confidence in the efficacy and safety of trifarotene vs. vehicle treatment at reducing atrophic acne scarring.

Galderma Achieves Record 2 B USD Net Sales for a Six-Month Period in H1 2023, as It Continues to Demonstrate Leading Execution and Innovation Capabilities in Dermatology

Retrieved on: 
Thursday, July 27, 2023
Cosmetics, Retail, Health, Medical Devices, Other Health, Clinical Trials, Pharmaceutical, Galderma, COVID-19, Sleep, Dermatology, Core, American Academy, Atopic dermatitis, Biostimulation, Patient, Growth, Prurigo nodularis, FDA, Nemolizumab, III, Skin, Neuromodulation, Pharmaceutical industry, Security (finance), Marketing, International, Prurigo

With its broad portfolio of leading brands and services, fueled by science-based innovation and focused commercial execution, Galderma is well positioned in a growing dermatology market.

Key Points: 
  • With its broad portfolio of leading brands and services, fueled by science-based innovation and focused commercial execution, Galderma is well positioned in a growing dermatology market.
  • Injectable Aesthetics delivered single-digit constant currency growth over the period, from a high comparative base in 2022.
  • While Galderma gained market share across its Injectable Aesthetic portfolio, Neuromodulators and Biostimulators stood out with double-digit constant currency growth for the period.
  • In the first half of 2023, Galderma continued to advance innovation, with significant launches and positive data presentations across its leading dermatology portfolio.

WCD 2023: Galderma to Present Extensive Data Demonstrating Enduring Commitment to Delivering Innovative Solutions in Dermatology

Retrieved on: 
Wednesday, June 28, 2023
Biotechnology, General Health, Other Health, Health, Pharmaceutical, START, Health care, Scar, Acne, Atopic dermatitis, Research, Prurigo, United States $1 Coin Act of 1997, Congress, IGA, WCD, Patient, Risk, Nemolizumab, III, George Washington University, Skin, Safety, Cosmetics, Galderma, Dermatology

Galderma will be presenting 59 abstracts/posters from across its extensive portfolio at the 25th World Congress of Dermatology (WCD), reflecting its unrelenting dedication to delivering innovative solutions to advance dermatology for every skin story.

Key Points: 
  • Galderma will be presenting 59 abstracts/posters from across its extensive portfolio at the 25th World Congress of Dermatology (WCD), reflecting its unrelenting dedication to delivering innovative solutions to advance dermatology for every skin story.
  • Galderma is the only pure-play dermatology company with more than 40 years of heritage, and its significant presence at the congress underscores its leadership in this space.
  • The WCD will take place in Singapore from July 3-8, 2023.
  • “The extent of our presence at the WCD this year – with nearly 60 abstracts/posters being presented – really exemplifies the strength of our dedication and offering in dermatology.

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.