Business Wire

LEO Pharma Receives Positive CHMP Opinion of Adtralza® (tralokinumab) for the Treatment of Adolescents 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 recommending to extend the approval of Adtralza® (tralokinumab) in the European Union (EU) to include adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. The recommended dose for adolescent patients is an initial dose of 600 mg followed by 300 mg administered every other week, which is the same dosing as for adult patients.

Adtralza, a high-affinity human monoclonal antibody,1 is approved for the treatment of adults with moderate-to-severe AD in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland.2 It also is approved for adults in the United States under the tradename Adbry™. It is not currently approved in any market for adolescent use.

“Today’s CHMP opinion underscores our confidence in the safety profile and effectiveness of Adtralza as we seek to obtain regulatory approval to expand its indication for use in an adolescent patient population,” said Christophe Bourdon, Chief Executive Officer, LEO Pharma A/S. “There are limited treatment options for adolescents in the EU living with moderate-to-severe atopic dermatitis. Through our clinical efforts, we have worked to ensure there is sufficient data to support bringing a new biologic option to market for these patients.”

The CHMP opinion is based on data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adtralza (150 mg or 300 mg) monotherapy compared to placebo in adolescents with moderate-to-severe AD who were candidates for systemic therapy. 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 were measured by extent and severity of atopic dermatitis (SCORAD), at least a 4-point improvement in adolescent weekly average Worst Daily Pruritus Numeric Rating Scale (NRS) score, and Children’s Dermatology Life Quality Index (CDLQI) score.3,4

The CHMP’s positive opinion will be reviewed by the European Commission (EC) and pending the final decision, the marketing authorization will be valid in all EU Member States, Iceland, Norway, and Liechtenstein. An additional regulatory filing is underway with the U.S. Food and Drug Administration (FDA).

About the ECZTRA 6 Trial

ECZTRA 6 (ECZema TRAlokinumab trial No. 6) is a randomized, double-blind, placebo-controlled, parallel-group, multinational 52-week trial, including a total of 301 patients (aged 12 to 17), with 289 (195 Adtralza patients and 94 placebo patients) in the full analysis set, evaluating the efficacy and safety of Adtralza (150 mg or 300 mg) monotherapy compared to placebo in adolescents with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.3,4

Following a washout period, patients were randomized to subcutaneous Adtralza 150 mg or 300 mg Q2W, or placebo for an initial 16 weeks. Adtralza dosing started with a 300 mg or 600 mg loading dose on day 0 for those receiving Adtralza 150 mg or 300 mg Q2W, respectively.3

At Week 16, patients who responded to Adtralza with an IGA score of 0/1 and/or EASI change of at least 75% from baseline, without use of rescue treatment, were re-randomized to Adtralza Q2W or Q4W for an additional 36 weeks. Patients not achieving primary endpoints at week 16, those receiving rescue treatment from week 2 to week 16, and those meeting other specific criteria were transferred to open-label treatment of Adtralza 300 mg Q2W plus optional mild-to-moderate strength topical corticosteroids.3

About atopic dermatitis

Atopic dermatitis 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 an important role in atopic dermatitis pathophysiology.7

About Adtralza® (tralokinumab)

Adtralza® (tralokinumab) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine1, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.2,7 Adtralza specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).1,7

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 5,800 people, serving millions of patients across the world. In 2021, the company generated net sales of DKK 9,957 million.

References

  1. 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.
  2. Adtralza® (tralokinumab) EU Product Information. LEO Pharma; June 2021.
  3. Paller A. Efficacy and safety of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: results of the phase 3 ECZTRA 6 trial. Fall Clinical. Oct. 21-24, 2021. Poster Presentation.
  4. ClinicalTrialsRegister.eu. Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6). Identifier: 2017-005143-33.
  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.
  7. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.

MAT-58697 September 2022

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

Contact information

David Patti
LEO Pharma, Global Product Communications
+1 973.796.7706
DAPAI@leo-pharma.com

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

Faster Recoveries, Improved Security: HTEC and G2 Risk Solutions Join Forces to Advance Bankruptcy Management28.3.2024 19:02:00 EET | Press release

HTEC, a global digital consulting, software engineering, and product development company, is announcing a strategic collaboration with G2 Risk Solutions (G2RS), the preeminent provider of end-to-end bankruptcy technology solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328622816/en/ HTEC & G2 Risk Solutions Partnership (Photo: Business Wire) Under the agreement, G2RS will engage HTEC to incorporate its leading-edge technology into G2RS’ premier bankruptcy management platform. As the creators of the most comprehensive national bankruptcy database and the first bankruptcy management portal, G2RS is an industry pioneer. By adding HTEC’s premium engineering to the G2RS technology stack, G2RS will offer new and innovative functionalities to help clients expedite financial recoveries, increase data protection, and reduce operational inefficiencies in the bankruptcy management life cycle. “We are thrilled to be a part o

LambdaTest Launches The Phoenix Project, an Employee Resource Group for Women28.3.2024 18:00:00 EET | Press release

LambdaTest, a leading cloud-based unified testing platform, announced the launch of The Phoenix Project, an Employee Resource Group (ERG) dedicated to supporting and promoting the success of its female employees. “LambdaTest is committed to fostering a diverse, inclusive, and equitable workplace where all employees feel valued and empowered to reach their full potential,” said Chandini Chopra, VP of People and Culture at LambdaTest. “The Phoenix Project is a critical step towards achieving this goal by providing a platform for professional development, networking, and mentorship, especially for our women employees.” The Phoenix Project Aims To: Offer professional development workshops, networking opportunities, and dedicated time off for women to participate in ERG initiatives. Provide mentorship programs connecting senior female employees with mentees. Promote leadership development among women within the company. Create a sense of community for women in the workplace. Leadership and

The reopening of the Yokohama Museum of Art adds another innovative and distinctive venue for events in Yokohama28.3.2024 18:00:00 EET | Press release

After extensive renovations, the iconic Yokohama Museum of Art has reopened its doors to visitors from all over the world. The museum’s reopening paves the way to new and closer collaboration with international events in Yokohama. This extraordinary venue is the ideal setting for a one-of-a-kind gathering, in part, supported by the Yokohama Convention & Visitors Bureau (hereinafter YCVB). The Yokohama Museum of Art Founded in 1989, the Yokohama Museum of Art collects over 14,000 works of art that reflect the many facets of life in Yokohama—past, present, and future. The reopening of the museum coincides with the Yokohama Triennale, an international exhibition featuring contemporary artists whose decentralized exhibits turn the entire metropolis into an art museum. The 8th Yokohama Triennale is being held from March 15 to June 9, 2024, with the Yokohama Museum of Art being a pivotal venue for the exhibition. With the museum firmly back on the map as Yokohama’s leading artistic venue, YC

Eight new sustainability-themed experiences—exclusive to Yokohama—for convention participants28.3.2024 18:00:00 EET | Press release

In a survey conducted by Yokohama Convention & Visitors Bureau (hereinafter YCVB), many convention attendees expressed particular interest in Yokohama’s culture, sightseeing spots, and local cuisine. In response, YCVB has developed eight new Yokohama Tours for event attendees to enjoy during their free time in Yokohama, keeping in line with our ethos of sustainability. Noge Area Bar-Hopping Tour, complete with guide Known affectionately by locals as Yokohama’s kitchen, Noge is a bustling nightlife spot that is home to over 600 izakaya (Japanese-style pubs). A knowledgeable local guide will lead participants to all the hidden gems in Noge, where they can indulge in distinctive, delicious pub-style food and drink. With easy on-foot accessibility, participants can rest assured this fun night out won’t impact their carbon footprint. Soto Zen Tour of Sojiji, head temple of the Soto Zen school As a prominent Zen sect in Japan, Soto Zen provides one of the best Zen wellness experiences. Durin

Nordson EFD Releases New 3-Axis Automated Fluid Dispensing Systems28.3.2024 17:00:00 EET | Press release

Nordson EFD , a Nordson company (NASDAQ: NDSN) and leading precision fluid dispensing systems manufacturer is proud to announce the new GVPlus and PROX families of automated fluid dispensing products. Both robotic solutions share a focus on motion, workspace, repeatability, payload, setup, and vision technology enhancements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240305726899/en/ The GV Series offers market-leading dimensional positional accuracy and deposit placement repeatability. (Photo: Business Wire) The new GVPlus automated fluid dispensing solution offers improved repeatability, bigger payloads with simplified setup requirements, and superior vision capabilities. Repeatability is now best-in-class at 8 μm, improving repeatability to ±0.008 mm. Setting up the robot is easier due to a new dual mounting flange that enables a tool payload of up to 4.5 kg (10 lbs). When paired with the working area of 400 mm x 400

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
HiddenA line styled icon from Orion Icon Library.Eye