Articles from Galderma
Galderma Receives U.S. FDA Approval for Nemluvio® (Nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis
Galderma (SWX:GALD) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nemluvio® (nemolizumab) for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. This follows the recent U.S. FDA approval of Nemluvio for subcutaneous injection for the treatment of adults with prurigo nodularis in August 2024.12
By Galderma · Via Business Wire · December 13, 2024
CHMP Recommends Approval of Galderma’s Nemolizumab for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis in the European Union
Galderma today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the European Union (EU). The CHMP has recommended nemolizumab’s approval for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. This follows its approval for the treatment of adults with prurigo nodularis by the United States (U.S.) Food and Drug Administration (FDA) in August 2024.14
By Galderma · Via Business Wire · December 13, 2024
Galderma’s Phase III OLYMPIA 1 Data Published in JAMA Dermatology Demonstrate That Nemolizumab Improves Core Signs and Symptoms of Prurigo Nodularis
Galderma (SWX:GALD) today announced that full results from the phase III OLYMPIA 1 trial, a 24-week study which evaluated the efficacy and safety of nemolizumab monotherapy in adults with moderate-to-severe prurigo nodularis, were published in JAMA Dermatology.1 The trial met both primary and all key secondary endpoints, showing that nemolizumab-treated patients had significantly higher improvements in itch and skin lesions when compared to those receiving placebo at Week 16, with a rapid and clinically meaningful response on itch and sleep disturbance observed as early as Week 4.1 Nemolizumab was well-tolerated, and its safety profile was generally consistent with previous studies.1
By Galderma · Via Business Wire · November 28, 2024
Celebrating 25 Years of Sculptra®: New Data and Recent Approval in China Cements Galderma’s Leadership in Regenerative Biostimulation
This month marks the 25th anniversary of the approval of Sculptra®, the first proven regenerative biostimulator with a unique poly-L-lactic acid (PLLA-SCA™) formulation.1-5,10-16 Sculptra works with the body’s natural processes to achieve healthier, radiant skin and a more youthful appearance, and has been a cornerstone of Galderma’s broad portfolio of proven aesthetic treatments.17,18 During its 25 years on the market, healthcare professionals have treated millions of patients with Sculptra, with distribution in over 40 countries and regions worldwide.10,12,19,20
By Galderma · Via Business Wire · November 4, 2024
Galderma Brings Together Over 650 Healthcare Professionals from Asia-Pacific to Elevate Knowledge of Future Aesthetic Trends
Galderma (SWX:GALD), the pure-play dermatology category leader, today announced a new edition of the Galderma Aesthetic Injector Network (GAIN) event in the Asia-Pacific region, which houses some of the company’s fastest growing markets. This is the largest regional event to date and will deliver a premium and engaging experience for more than 650 delegates. Taking place October 26-27 in Incheon, South Korea, the extensive, two-day agenda will take a deep dive into the six trends identified in the ‘NEXT by Galderma’ report and explore how they will shape the future of aesthetics.1
By Galderma · Via Business Wire · October 25, 2024
ASDS 2024: New Phase III READY-4 Data Demonstrate Long-Term Safety and Efficacy of Galderma’s RelabotulinumtoxinA (Relfydess™)
Galderma today announced new phase III data from the READY-4 clinical trial, demonstrating the long-term safety of RelabotulinumtoxinA (Relfydess™) for frown lines and crow’s feet after repeated injections.1 The READY-4 study met its primary and secondary endpoints, with less than one in five participants experiencing treatment-related treatment-emergent adverse events (TEAEs), and all events deemed mild or moderate.1 Efficacy and patient satisfaction were also maintained across multiple treatments.1 The data were presented at the American Society for Dermatologic Surgery (ASDS) 2024 Annual Meeting, held in Florida from October 17-20.
By Galderma · Via Business Wire · October 21, 2024
EADV 2024 Late Breaking News Sessions: New Galderma Data Demonstrating Nemolizumab’s Long-term Efficacy and Safety in Atopic Dermatitis and Durability in Prurigo Nodularis to Be Shared During Three Oral Presentations
Galderma today announced that it will present new data from the ARCADIA and OLYMPIA clinical trial programs investigating nemolizumab in atopic dermatitis and prurigo nodularis, respectively, at the 2024 European Academy of Dermatology and Venereology (EADV) congress in Amsterdam during three separate oral presentations. These late-breaking data will be presented on Wednesday, September 25, including long-term efficacy and safety results from an interim analysis of the phase III ARCADIA long-term extension study and novel biomarker analyses of nemolizumab in adolescents and adults with moderate-to-severe atopic dermatitis.1,2 Additionally, encouraging data from the phase IIIb OLYMPIA DURABILITY study documenting durability of response to nemolizumab in adults with prurigo nodularis will also be presented.3
By Galderma · Via Business Wire · September 25, 2024
Galderma Reaffirms Its Leadership in Dermatology With Extensive Presence at EADV 2024
Galderma (SWX:GALD), the pure-play dermatology category leader, announced today it will be showcasing updates from across its industry-leading dermatology portfolio at the 33rd European Academy of Dermatology and Venereology (EADV) congress taking place in Amsterdam, September 25-28, 2024, reinforcing its commitment to advancing dermatology for every skin story. In addition to presenting 30 abstracts with data on prurigo nodularis, atopic dermatitis, sensitive skin and acne, Galderma will host a series of events dedicated to addressing the real needs of patients and connecting with the dermatology community, including a symposium and several industry hub sessions and Meet the Experts sessions at the Galderma booth.
By Galderma · Via Business Wire · September 17, 2024
Galderma Receives U.S. FDA Approval for Nemluvio® (nemolizumab) for Adult Patients Living With Prurigo Nodularis
Galderma today announced that the U.S. Food and Drug Administration (FDA) has approved Nemluvio® (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.1 Nemluvio was granted Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024 by the U.S. FDA – a status reserved for medicines with the potential to significantly improve the treatment of serious conditions.
By Galderma · Via Business Wire · August 13, 2024
Galderma to pursue a new scientific partnership with L’Oréal to further advance its category leadership in dermatology
Galderma today announced that it has signed a memorandum of understanding with L’Oréal to work towards a new research and development (R&D) collaboration in the form of a scientific partnership focused on complementary research projects which could develop advanced, future-proof technologies with direct applications in the field of dermatology.
By Galderma · Via Business Wire · August 5, 2024
Galderma’s Relfydess™ (RelabotulinumtoxinA) Receives Positive Decision for Use in Europe
Galderma today announced that it has completed its European decentralized procedure (DCP), resulting in a positive decision for RelfydessTM (RelabotulinumtoxinA – previously referred to as QM1114). RelfydessTM is indicated for the temporary improvement in the appearance of moderate-to-severe glabellar lines (frown lines) at maximum frown and lateral canthal lines (crow’s feet) seen at maximum smile, alone or in combination, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.9 Following the successful completion of the DCP, national approvals in the 16 concerned countries are now under finalization. RelfydessTM also received a marketing authorization in Australia earlier this year.
By Galderma · Via Business Wire · July 30, 2024
PHASE III ARCADIA 1 and 2 Trial Primary Results Published in The Lancet: Galderma’s Nemolizumab Improves Key Aspects of Atopic Dermatitis – Itch, Skin Lesions and Sleep Disturbance
Galderma today announced that full results from the phase III ARCADIA 1 and 2 clinical trials in atopic dermatitis were published in The Lancet.1The trials evaluated the efficacy and safety of nemolizumab in combination with background topical corticosteroids (TCS), with or without topical calcineurin inhibitors (TCI), versus placebo in combination with TCS, with or without TCI, in adolescent and adult patients with moderate-to-severe atopic dermatitis.1 Results show that the trials met their co-primary and all key secondary endpoints, showing that nemolizumab significantly improved skin lesions, itch and sleep disturbance by Week 16 when compared to placebo, with significant itch relief observed as early as Week 1.1
By Galderma · Via Business Wire · July 25, 2024
Galderma Introduces High Potency Cetaphil Serums Designed for Sensitive Skin
Galderma announced today the exclusive launch in the U.S. of its latest innovations in its Cetaphil range of products: a Vitamin C Serum and a Ceramide Serum.
By Galderma · Via Business Wire · July 9, 2024
Galderma Granted Key Manufacturing License Updates for New Biologics Capabilities at Its Center of Excellence
Galderma today announced that the Swedish Medical Products Agency (Läkemedelsverket) issued key manufacturing license updates that will allow the company to pursue its ambitious growth and innovation roadmap.
By Galderma · Via Business Wire · June 19, 2024
Galderma Launches Restylane® VOLYME™ in China – One of the World’s Fastest Growing Aesthetics Markets
Galderma (SWX:GALD) announced today the launch of its hyaluronic acid injectable filler, Restylane® VOLYME™ in China. The company is also introducing its complementary Shape Up Holistic Individualized Treatment (HIT™) in the country, which addresses aging concerns caused by loss of structural support in the mid-face. The availability of these targeted solutions for the mid-face region is demonstrative of Galderma’s commitment to meeting patient and injector needs in China. In the past decade, the growth of China’s aesthetics medicine market has outpaced the global market; with relatively low market penetration, there remains significant potential for future growth.1
By Galderma · Via Business Wire · May 23, 2024
AMWC 2024: Galderma to Share New Data From Its Leading Injectable Aesthetic Portfolio
Galderma will present the latest updates from its broad portfolio of clinically-proven and holistic range of aesthetic treatments at the 22nd Aesthetic & Anti-Aging Medicine World Congress (AMWC) on March 27-29, 2024. The diversity of Galderma’s portfolio, designed to meet the individual needs of healthcare professionals and patients, will be showcased in 16 research posters – including data from the world’s most diverse range of fillers (Restylane®), leading neuromodulator portfolio (RelabotulinumtoxinA, Alluzience® and Azzalure®) and original biostimulator (Sculptra®) – as well as two symposia and a booth, which will host an array of live demonstrations and ‘Meet the Expert’ sessions.
By Galderma · Via Business Wire · March 19, 2024
Galderma @ AAD 2024: New Data Demonstrate the Long-Term Efficacy of Nemolizumab in Prurigo Nodularis and Its Durability in Atopic Dermatitis
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.
By Galderma · Via Business Wire · March 10, 2024
Galderma Announces Record 2023 Net Sales of Over 4 B USD and Significant Core EBITDA Margin Expansion
Galderma:
By Galderma · Via Business Wire · February 29, 2024
Galderma to Showcase Latest Updates From Its Broad, Innovative and Leading Dermatology Portfolio at the 2024 American Academy of Dermatology Annual Meeting
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. Galderma’s extensive presence – including two late-breaking presentations on its first-in-class, investigational monoclonal antibody nemolizumab, five oral poster presentations, 16 e-posters, a symposium, and several ‘Meet the Expert’ and interactive booth sessions – highlights its commitment to listening to consumers, patients and healthcare professionals in order to deliver cutting-edge science and innovation that addresses their varied needs.
By Galderma · Via Business Wire · February 28, 2024
CORRECTING and REPLACING, Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in the U.S. and EU
Correction by Galderma: Results from the OLYMPIA program demonstrated that more than half of nemolizumab-treated patients achieved an at least four-point reduction in itch intensity, as measured by the peak-pruritus numerical rating scale (PP-NRS; 58% and 56% in OLYMPIA 1 and 2, respectively, compared to 17% and 21% in the placebo groups; p<0.0001).
By Galderma · Via Business Wire · February 14, 2024
Galderma Takes the ‘Face of Cetaphil®’ to the Runway at New York Fashion Week
Cetaphil®, a leading dermatologist-recommended sensitive skincare brand, is launching a first-of-its-kind global skincare immersion. This immersion will put the sensitive skin science behind its formulas to the ‘ultimate skin stress test’ at New York Fashion Week (NYFW).
By Galderma · Via Business Wire · February 8, 2024
Galderma Launches ‘NEXT’, a Ground-Breaking Trend Report That Unveils the Future of Aesthetics
Galderma, the emerging pure-play dermatology category leader, is proud to present “NEXT by Galderma.” A ground-breaking report, NEXT takes a deep-dive into the global aesthetics trends set to shape 2024 and beyond. This project is the culmination of a year of comprehensive trend-forecasting research, conducted in collaboration with a network of renowned experts.
By Galderma · Via Business Wire · February 7, 2024
Galderma Celebrates 25 Years of Excellence in Biostimulation With Sculptra® at the 2024 IMCAS
Galderma, the emerging pure-play dermatology category leader, is proud to celebrate 25 years of Sculptra®, which enjoys the trust of healthcare professionals and unmatched patient satisfaction. Sculptra is the first and original biostimulator, with a unique PLLA-SCA™ formulation that activates the skin’s natural power to revitalize collagen production for a more youthful appearance.
By Galderma · Via Business Wire · February 2, 2024
IMCAS 2024: Galderma to Present Latest Updates From Its Unparalleled Aesthetics Portfolio Reinforcing Its Leadership Position
Galderma will be sharing the latest updates from across its broad and unparalleled portfolio at the International Master Course on Aging Science (IMCAS) World Congress 2024 from February 1-3, 2024, in Paris. The updates reinforce Galderma’s leadership in aesthetic injectables and dermatological skincare. In addition to presenting 10 research posters highlighting data from across the portfolio —including on our investigational neuromodulator RelabotulinumtoxinA — Galderma will host a number of events dedicated to addressing the real needs of physicians. This will include three symposia and several ‘Meet the Expert’ and interactive booth sessions.
By Galderma · Via Business Wire · January 25, 2024
Galderma Announces Regulatory Approval for Restylane® SHAYPE™, a New Hyaluronic Acid Injectable Designed for Augmenting the Chin Region
Galderma, the emerging pure-play dermatology category leader, announced today it has received approval from Health Canada for Restylane® SHAYPE™, a hyaluronic acid (HA) injectable designed for temporary augmentation of the chin region.2 Engineered to build and shape on bone with deep injection for a bone-mimicking effect,1,2,3,4† Restylane® SHAYPE™ will be available in Canada as of February 2024.
By Galderma · Via Business Wire · January 22, 2024