Business Wire

LEO Pharma Receives Positive CHMP Opinion of Adtralza ® (tralokinumab) for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis

Share

LEO Pharma A/S, a global leader in medical dermatology, 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 a marketing authorization of Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

The CHMP positive opinion is one of the final steps before the European Commission makes its decision on the Marketing Authorization Application for use of Adtralza, an investigational therapy in clinical development, throughout the European Union. This final decision is expected in the coming months and if authorized, Adtralza will be the first fully human, monoclonal antibody available to specifically target the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms. Adtralza specifically targets IL-13 with high affinity and is developed to improve the symptoms of atopic dermatitis, which is a complex and chronic inflammatory skin condition.1,2

“Atopic dermatitis is characterized by its unpredictability, which can be challenging for patients who often experience physical discomfort and emotional effects that may continue for decades,”said Jörg Möller, Executive Vice President, Global Research and Development, LEO Pharma. “Today’s CHMP opinion brings LEO Pharma one step closer to the potential of providing Adtralza as a new therapeutic option for EU patients living with moderate-to-severe atopic dermatitis.”

The CHMP opinion is based primarily on data from three pivotal randomized, double-blind, placebo-controlled trials (ECZTRA 1, 2 and ECZTRA 3), which evaluated the safety and efficacy of Adtralza as monotherapy and with concomitant topical corticosteroids (TCS) in more than 1,900 adult patients with moderate-to-severe atopic dermatitis. Primary endpoints were the Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75).3,4

Secondary endpoints, including the extent and severity of skin lesions, pruritus (itch), sleep and health-related quality of life measures, were measured by changes in the following scores: EASI-90, SCORing Atopic Dermatitis (SCORAD), Pruritus Numeric Rating Scale (NRS), Eczema-Related Sleep NRS and Dermatology Life Quality Index (DLQI). The trials demonstrated that Adtralza met the primary and secondary efficacy endpoints and was generally well tolerated.3,4

Pending the final decision from the European Commission, the marketing authorization will be valid in all European Union Member States, Iceland, Norway, and Liechtenstein. Additional regulatory filings are underway [with the U.S. Food and Drug Administration (FDA)] and other health authorities worldwide.

About Adtralza (tralokinumab)

Adtralza (tralokinumab) is a fully human, monoclonal antibody developed to specifically neutralize the IL-13 cytokine, which plays a key role in the immune process underlying atopic dermatitis signs and symptoms. Adtralza specifically binds to the IL-13 cytokine with high affinity, thereby preventing interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).1,2

About the pivotal ECZTRA 1, 2, and ECZTRA 3 Trials

ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials Nos. 1 and 2) were randomized, double-blind, placebo-controlled, multinational 52-week trials, which included 802 and 794 adult patients, respectively, to evaluate the safety and efficacy of Adtralza (300 mg) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.3

ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week trial, which included 380 adult patients, to evaluate the safety and efficacy of Adtralza (300 mg) in combination with TCS in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.4

About atopic dermatitis

Atopic dermatitis (AD) is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.5 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.6 Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.1

About LEO Pharma

LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. [In 2020, the company generated net sales of DKK 10,133 million]. For more information please visit www.LEO-Pharma.com

References

  1. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
  2. Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017; 429:208–19.
  3. Wollenberg A, et al. Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐week, randomized, double‐blind, multicentre, placebo‐controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021; 437-449.
  4. Silverberg JI, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate‐to‐severe atopic dermatitis: results from the double‐blind, randomized, multicentre, placebo‐controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021; 450-463.
  5. Weidinger S, et al. Atopic dermatitis. Lancet. 2016; 387:1109-1122.
  6. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.

April 2021 MAT-42443

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Linda Mayer
Global Product Communications
+1 973 908 7924
limay@leo-pharma.com

Henrik Kyndlev
Global External Communications
+45 3140 6180
hdtdk@leo-pharma.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

SentinelOne Receives Highest Score for the Type C Use Case in the Gartner 2021 Critical Capabilities for Endpoint Protection Platforms14.5.2021 16:00:00 CEST | Press release

SentinelOne, the autonomous cybersecurity platform company, today announced that Gartner has positioned SentinelOne with the highest score in customer use case C in Gartner’s 2021 Critical Capabilities for Endpoint Protection Platforms report1. SentinelOne also received the highest score across all three Critical Capabilities use cases out of the 19 vendors included in the report. According to Gartner, “Type C organizations typically view technology as an expense or operational necessity and use it as a means to reduce costs.” Additionally, Gartner comments, “For EPP, these organizations focus on prevention, rather than on integrated detection and response capabilities and solutions that offer a complement of managed services.” “Recognition for this use case is a testament to SentinelOne’s ability to offer cost-effective and efficient solutions for enterprises of all types, including those who need to prioritize innovation and capabilities with budget and operational constraints,” said

Wipro Limited Appoints Tulsi Naidu to Its Board14.5.2021 14:22:00 CEST | Press release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced the appointment of Ms. Tulsi Naidu, a widely respected business leader, to its Board of Directors for five years effective July 1, 2021, subject to the approval of shareholders. Tulsi Naidu will serve as an Independent Director on the Board and bring a wealth of experience to Wipro, having spent 25 years in the global financial services sector. Ms. Naidu is CEO Asia Pacific of Zurich Insurance Group (Zurich) and a member of Zurich’s Executive Committee. She joined Zurich in September 2016 and was named the CEO of the UK business in November 2016 where she implemented an extensive transformation program – reshaping the business, simplifying the structure, improving technical and digital capabilities, and positioning it for growth in its core markets. Before joining Zurich, Ms. Naidu spent 14 years at Prudential in various executiv

REPLY: The Board of Directors Approves the Quarterly Report Dated 31 March 202114.5.2021 12:49:00 CEST | Press release

Today, the Board of Directors of Reply S.p.A. [MTA, STAR: REY] approved the results as at 31 March 2021. Since the beginning of the year, the Group has recorded a consolidated turnover amounting to €352.4 million, an increase of 11.2% compared to the corresponding data for 2020. All indicators are positive for the period. In the first quarter of 2021 the consolidated EBITDA was €59.6 million compared to €47.6 million in 2020, equal to 16.9% of the turnover. EBIT, from January to March, was €47.9 million (€38.0 million in 2020), and is equal to 13.6% of the turnover. The profit before tax, from January to March 2021, was €47.6 million (€33.9 million in 2020), equal to 13.5% of the turnover. The net financial position of the Group on 31 March 2021 is also positive by 227.9 million. The net financial position on 31 December 2020 was positive for €158.7 million. “"The first quarter of 2021 - stated Mario Rizzante, Reply's Chairman - was very positive, both in terms of revenue and margin gr

PMC Biogenix Announces Price Increase on Armoslip® and Kemamide® Fatty Amides14.5.2021 11:00:00 CEST | Press release

PMC Biogenix Inc. announces that effective June 1, 2021 or as contracts permit, prices for Armoslip and Kemamide brand primary and secondary fatty amides and bisamides will increase by $1.00 to $3.00 per kilo for all orders, globally; adjusted for currency fluctuations. This increase is necessary to counterbalance the unprecedented and rapid rate of raw material and logistical cost increases and to continue providing the world class service expected by our global customer base. Customers with questions should contact their local sales manager. About PMC PMC Group is a growth oriented, diversified, global chemicals and plastics company dedicated to innovative solutions to everyday needs in a broad range of end markets including plastics, consumer products, electronics, paints, packaging, personal care, food, automotive and pharmaceuticals. The Company was built on a sustainable model of growth through innovation while promoting social good. PMC operates from a global manufacturing, inno

Mavenir Wins Award for Multi-G Open RAN Small Cell Solutions14.5.2021 09:00:00 CEST | Press release

Mavenir, the Network Software Provider building the future of networks with cloud-native software that runs on any cloud and transforms the way the world connects, is pleased to announce that it has won the Small Cell Forum Judges’ Choice award for its role in transforming mobile networks through its Multi-G Open RAN small cell solutions and its Mobile Network Operator (MNO) Open RAN neutral host integration. Multi-G Open RAN small cell solutions: Adding 2G/3G across a single unified RAN to support Multi-G radio access in 2020, Mavenir extended its Open Radio Access Network (Open RAN) capabilities across 2G, 3G, 4G and 5G to offer MNOs and enterprises a complete end-to-end, software-centric network proposition, spanning small cell radios to converged packet core to digital enablement solutions. This enables the move towards one network, rather than managing cost and complexity of several different networks. With a seamless, multi radio access technology (Multi-RAT) single RAN solution,

Swimlane and Elastic Partner to Deliver an Extensible Framework for Security Operations Teams13.5.2021 22:30:00 CEST | Press release

Swimlane, provider of the industry's leading security automation platform, and Elastic (NYSE: ESTC), the company behind Elasticsearch and the Elastic Stack, today announced a strategic partnership to help global security teams break down silos in their security processes, and provide a force multiplier to security operations teams that are perpetually overwhelmed. This partnership will enhance existing product integrations and jointly develop new capabilities to help security teams be more efficient and effective in protecting their organizations. The combined power of scale and automation Key integrations will enable even highly distributed security operations teams to significantly reduce friction associated with context-gathering tasks and threat containment — providing critical time savings that help analysts triage alerts quickly while minimizing damage from threats. Swimlane and Elastic plan further enhancements to the product experience through: An extensible framework that exte

IFF Achieves Key 2020 Sustainability Goals13.5.2021 22:15:00 CEST | Press release

IFF (NYSE:IFF) today announced the achievement of key 2020 sustainability goals that were set at the launch of the Company’s sustainability program in 2010. During that time, IFF met and surpassed its original intensity-based targets for three environmental goals, resulting in a reduction in its greenhouse gas (GHG) emissions, water withdrawal and hazardous waste generation per metric ton of production by -42.6%, -67.1% and -41% below 2010 levels, respectively. IFF has also achieved its 2020 goal to have 100% of the palm oil used in its products be certified according to the Roundtable on Sustainable Palm Oil (RSPO) Mass Balance Supply Chain Model. These and other milestones are captured in its latest Sustainability Report, “For a Better World,” which is published today. The title references the Company’s purpose – Applying science and creativity for a better world – a clear and bold aspiration that inspires everyone at IFF to push past traditional boundaries and to be a force for a be