Galderma Investigational Therapy Nemolizumab Granted FDA Breakthrough Therapy Designation for the Treatment of Patients Suffering from Prurigo Nodularis
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. It frequently leads to a severe quality of life impairment.
Nemolizumab is a first-in-class investigational monoclonal antibody that blocks signaling of IL-31. Galderma recently presented, at the 28th Annual Congress of the European Academy of Dermatology and Venereology, the results of a Phase 2 study in adult patients with moderate-to-severe prurigo nodularis. Nemolizumab not only met the primary endpoint of a greater improvement in peak pruritus Numerical Rating Scale (PP NRS) from baseline compared to placebo, but also significantly improved skin lesions as measured by Investigator Global Assessment (IGA).
Dr Thibaud Portal, Galderma Global Vice President of Prescription medicines, commented: “With the Phase 2 study results, we were able to provide substantial clinical evidence supporting the Breakthrough Therapy Designation now granted by the U.S. FDA. 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. We are fully committed to continue driving forward the overall nemolizumab development program.”
Galderma is now actively preparing for the initiation of a Phase 3 pivotal program with nemolizumab in adult patients with prurigo nodularis in 2020.
Earlier this year, Galderma announced the enrollment of the first patients in the Phase 3 pivotal program with nemolizumab in adult patients with moderate-to-severe atopic dermatitis.
About the Breakthrough Therapy Designation
Therapies that are granted Breakthrough Therapy Designation by the U.S. FDA target serious or life-threatening diseases or conditions and provide preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
Nemolizumab, a first-in-class humanized monoclonal antibody, is directed against the IL-31 receptor alpha, which blocks signaling from IL-31. Nemolizumab, initially developed by Chugai Pharmaceutical Co., Ltd., was subsequently licensed to Galderma in 2016 – worldwide except Japan and Taiwan. Nemolizumab is an investigational agent under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com
Sébastien Cros, Head of Corporate Communications, firstname.lastname@example.org
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Science, Data, and Facts Should Unite Decision-Making, Says PMI CEO in Speech at Concordia Summit24.9.2020 22:20:00 EEST | Press release
André Calantzopoulos, CEO of Philip Morris International (PMI) (NYSE: PM), today delivered high-level remarks at the 2020 Concordia Annual Summit. Calantzopoulos discussed the impact that uncertainty, polarization, hyperpartisanship, and ideology are having on international efforts to overcome pressing global issues. He called for science to be protected from politicization and highlighted the importance of developing open dialogues based on factual scientific objectivity. Calantzopoulos shared PMI’s belief that with the right regulatory encouragement and support from civil society, cigarette sales can end within 10 to 15 years in many countries. The Concordia Annual Summit, which coincides with the United Nations General Assembly (UNGA) meeting, convenes the world’s most prominent business, government, and nonprofit leaders to foster dialogue and enable effective partnerships for positive social impact. Excerpts of the remarks by André Calantzopoulos follow: “Reflecting on the state o
Swiss Medical Group Holding Acquires CoreMedica Europe24.9.2020 18:54:00 EEST | Press release
Swiss Medical Group (SMG) Holding Luxembourg S.A., leading the development of STARKS Age-Management in Europe and Asia, announced today the acquisition of CoreMedica Europe, to expand in Europe and the rest of the world. CoreMedica Europe recently made the headlines in Switzerland for combining a COVID-19 Screening Test and Immunity profile with its existing home self-collection kit that allows customers to collect a few drops of blood and send them by mail to CoreMedica Europe’s accredited laboratory in Geneva to screen the anti-SARS-COV-2 IgG antibody and assess any previous infection to SARS-COV-2, the virus responsible for COVID disease, and analyze a set of 5 key biomarkers known to support the immune system (vitamin D, zinc, magnesium, copper, selenium) so as to receive personalized actionable recommendations to help patients build up their natural defenses against the effects of a next potential viral infection. “In this epidemic and containment context the essential objective
Esri and AfroChampions Launch Partnership to Promote GIS in Africa24.9.2020 16:52:00 EEST | Press release
Esri, the global leader in location intelligence, today announced a joint initiative with AfroChampions, a Pan-African nonprofit that aims to promote policies that foster private-public collaboration for Africa's economic transformation. The goal of the initiative is to engage leaders in business, governments, the African Union, and other regional economic communities through dialogue and potential partnership building in applying geospatial technology and solutions. This new partnership with AfroChampions seeks to contribute to sustainable economic development in Africa and promote the benefits of a shared geospatial infrastructure throughout the continent. As a majority of Africans still live in rural areas, geographic information system (GIS) technology can create new opportunities for growth, especially in critical fields such as health and telemedicine, land management, agriculture, and mobility. The powerful mapping and data analytics that GIS provides forms a foundation for some
DXC Technology Announces Leadership Appointments to Support the “new DXC"24.9.2020 16:20:00 EEST | Press release
DXC Technology (NYSE:DXC) today presented its latest leadership appointments further strengthening the DXC leadership team, the majority being new to DXC within the last year. This team is bringing the “new DXC,” which is focused on its customers and its people, to the market as it executes the company’s transformation journey. DXC Customer Portfolio Leadership Over the past year, CEO Mike Salvino has recruited new IT services industry leaders who bring formidable experience delivering for customers, inspiring people, and running and growing businesses. DXC announces the following appointments and changes to the team that will run DXC’s business and lead execution of the DXC transformation journey: Americas will be led by Jim Brady and David Swift . Jim joined DXC in June 2020 from Accumen, where he was the COO and previously worked at Accenture and Honeywell. David Swift joined DXC in November 2019 from Accolade where he was Chief Service Officer and previously worked at Aon Hewitt an
Statement on One-Year Anniversary of Women’s Entrepreneurship Accelerator24.9.2020 16:07:00 EEST | Press release
Please find the statement below from Women’s Entrepreneurship Accelerator leadership regarding the one-year anniversary of the ground-breaking initiative. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005283/en/ Anita Bhatia, Deputy Executive Director, UN Women One year ago, we committed to educating and empowering ten million women entrepreneurs over the next ten years through the Women’s Entrepreneurship Accelerator (WEA). We began to lay the groundwork for a systemic transformation to break down the barriers keeping women from achieving financial independence and contributing to a better future for themselves and their communities. Today, in our unprecedented reality, women find themselves at history’s crossroads. They are disproportionately harmed by the economic devastation wrought by COVID-19 while simultaneously holding the keys to recovery. Women make up 39% of global employment but have accounted for 54% of o
Airship Acquires Conversational Commerce Pioneer ReplyBuy to Accelerate Expansion Into Mobile Commerce24.9.2020 16:00:00 EEST | Press release
Customer engagement company Airship today announced that it has acquired ReplyBuy, a company that pioneered fully integrated solutions for payments over SMS. This move extends Airship’s platform beyond customer engagement to directly enable commerce, as well as power one-to-one customer conversations via two-way SMS. In addition, Airship plans to extend ReplyBuy’s technology to provide turnkey commerce and payments solutions across more marketing channels, messaging platforms and industry verticals. The acquisition will provide companies of all sizes a single platform to create, manage and optimize cross-channel customer interactions and drive greater revenue more quickly. Airship’s real-time mobile data, predictive AI and unified approach to customer journeys ensures relevant messaging at the optimal time on customers’ preferred channels across app and web notifications, SMS, email, mobile wallet and more. Subsequent digital actions customers take, now including purchases and conversa
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom