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-- New mechanistic research and clinician-reported real-world experience adds to the evolving evidence base for birch triterpenes in EB --

-- Chiesi proudly marks EB Awareness Week (October 25–31) with continued research, awareness and support for the EB community --

BOSTON, Oct. 15, 2026 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, today announced the presentation of new scientific data and real-world experience relating to FILSUVEZ^® (birch triterpenes) topical gel at the 14^th Annual Conference of the Pediatric Dermatology Research Alliance (PeDRA), to be held October 15–17, 2026, in Alexandria, Virginia. The presentations add to a growing body of real-world clinical evidence and scientific data, providing further insights into FILSUVEZ^® (birch triterpenes topical gel) in clinical practice and advancing scientific understanding of its mechanism of action. FILSUVEZ was approved by the U.S. Food and Drug Administration (FDA) in December 2023 for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older and was previously approved for the same indication by the European Commission in June 2022 and by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2022.

Together, the PeDRA presentations will bring new and evolving insights to the pediatric dermatology community. Two of the three presentations build on real-world experience and scientific evidence presented in 2026, including an expanded analysis of mechanism-of-action data introduced at the 55^th Annual European Society for Dermatological Research (ESDR) Meeting in September, and additional real-world experience with birch triterpenes as part of combination treatment approaches first shared at the 51^st Annual Society for Pediatric Dermatology (SPD) Meeting in July. A third presentation will share new real-world observations, for the first time at PeDRA, on the use of birch triterpenes in adolescents with chronic, life-long wounds.

“For a condition such as epidermolysis bullosa, where long-term clinical experience is essential, real-world evidence can provide important insights into how wound management approaches are being used across different care settings,” said Dr. Lara Wine Lee, MD, PhD, FAAD, Pediatric Dermatologist at Medical University of South Carolina. “Sharing these observations alongside mechanistic research helps expand the evidence base and identify questions that warrant further investigation, ultimately contributing to continued learning across the EB community.”

“Every piece of evidence generated through research and clinical experience is ultimately in service of people living with epidermolysis bullosa and their families,” said Rachele Berria, MD, PhD, Senior Vice President, Medical Affairs of Chiesi Global Rare Diseases. “This year’s research is especially meaningful because it brings together laboratory insights and real clinical care. Combining what we learn about birch triterpenes with what clinicians experience caring for patients helps guide where the science needs to go next. Heading into EB Awareness Week, we are proud to support research that brings real progress to the EB community.”

For Chiesi, advancing the science is only one part of showing up for the EB community. As the global EB community comes together for EB Awareness Week (October 25-31), Chiesi continues to support initiatives that amplify the voices and everyday experiences of people living with EB. These include the LivingWithEB platform, a digital space where people with EB can connect through personal stories and disease information, and the amplification of DEBRA International's Inside Out campaign, which brings greater visibility to the often-unseen impact of EB in daily life. Together, these efforts reflect Chiesi’s commitment to listening to and working alongside the EB community to increase understanding and help advance better care for those living with this rare disease.

Details of the three presentations at PeDRA 2026 include:

Title: Birch Triterpenes in Chronic Wound Healing: Real-World Experience in Adolescents with Epidermolysis Bullosa
Presenter: Hanna Ługowska-Umer, MD, PhD, Medical University of Gdańsk, Gdańsk, Poland
Format: Poster presentation
Topic: This case series will describe clinical experience with birch triterpenes in three adolescents with recessive dystrophic EB and chronic, lifelong wounds.

Title: Mechanism of Action of Triterpene Extract in Epidermolysis Bullosa: Suppression Followed by Activation
Presenter: Alexander Nyström, PhD, University of Freiburg
Format: Poster presentation

Title: Birch Triterpenes as a Core Component of Concomitant Therapy in Dystrophic Epidermolysis Bullosa: Real-World Experience
Presenter: Amy Paller, MD, Northwestern University Feinberg School of Medicine
Format: Poster presentation

FILSUVEZ was approved by the U.S. Food and Drug Administration (FDA) in 2023 and the European Commission in 2022 for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB). In Australia, FILSUVEZ was registered on the Australian Register of Therapeutic Goods (ARTG) on May 5, 2026. In Canada, FILSUVEZ is currently under review by Health Canada and has not received market authorization.

Important Safety Information and Indication

What is FILSUVEZ (birch triterpenes) topical gel for?

FILSUVEZ is a prescription medicine used on the skin to treat wounds that may happen with dystrophic and junctional epidermolysis bullosa (EB) in adults and children 6 months of age and older.

It is not known if FILSUVEZ is safe and effective in children younger than 6 months of age.

What is the most important safety information I should know?

FILSUVEZ may cause a serious side effect of allergic reactions.

Allergic reactions and skin reactions to FILSUVEZ may include the following symptoms: red itchy bumps (hives), skin rash, redness or itching. If you get any of these symptoms, stop using FILSUVEZ right away and call your healthcare provider.

What are the possible side effects of FILSUVEZ?

The most common side effect of FILSUVEZ is application site reactions, such as pain and itchy skin.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I use FILSUVEZ?

See the detailed “Instructions for Use” that comes with FILSUVEZ for information on how to apply FILSUVEZ.

Use FILSUVEZ exactly as your healthcare provider tells you to use it.

The tube of FILSUVEZ is for one-time use only. After the tube has been opened, apply the gel right away. Throw away any remaining gel and the tube after use.

Do not use around or get FILSUVEZ in the eyes, or mucous membrane areas, examples are mouth, vagina or anus.

If you get FILSUVEZ in your eyes or mucous membrane area, rinse with clean water right away. Contact your healthcare provider if you have any discomfort.

If the wounds you are treating with FILSUVEZ become infected, stop treatment and contact your healthcare provider. Signs or symptoms of infection may include the wound becoming red, warm, swollen, painful or drains yellow or greenish fluid (pus).

Please see Full Product Information and Patient Information.

About FILSUVEZ Topical Gel
FILSUVEZ^® (birch triterpenes) topical gel is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older. FILSUVEZ is applied as a 1 mm layer to the affected wound surface and covered with a wound dressing. Alternatively, FILSUVEZ may be applied directly to the dressing so that the topical gel is in direct contact with the wound. FILSUVEZ should be applied at wound dressing changes until the wound is healed.¹

About Epidermolysis Bullosa
Epidermolysis bullosa (EB) is a rare genetic disorder characterized by extreme skin fragility and blistering. Severe forms lead to chronic blisters, ulcerations, scarring, joint contractures, esophageal strictures, a high risk of squamous cell carcinoma, infections and premature death.²

Epidermolysis Bullosa is a group of rare, inherited skin fragility disorders in which the skin is very weak and fragile. Even minor friction to the skin can cause painful blisters and open wounds that are slow to heal and can lead to significant scarring.² Not only does EB affect the external skin, but the lining of the mouth, throat, eyes, and the digestive system.³ There are four main types of EB and they range in how severely they affect a person. The most severe forms are junctional EB (JEB) and dystrophic EB (DEB). These severe EB subtypes may be accompanied by multiple complications (e.g. sepsis, failure to thrive, severe anemia, and cancer) leading to a reduced lifespan. People with EB must take extraordinary measures to protect their fragile skin, and despite their efforts, many live with chronic wounds all over their body. These wounds are extremely painful and itchy.³ Pain can be persistent and severe in EB patients.⁴ Globally, an estimated 500,000 people are living with EB.⁵

About Chiesi Group
Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. 

By adopting the legal form of Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. Chiesi is committed to the principles that underpin the B Corp movement and aims to reach Net-Zero greenhouse gas (GHG) emissions by 2035.

With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 30 affiliates worldwide, and counts more than 7,900 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. 
For further information please visit www.chiesi.com or the website of your local Chiesi affiliate. 

About Chiesi Global Rare Diseases
Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have a therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system.

In 2026, Chiesi Group acquired KalVista Pharmaceuticals, a global pharmaceutical company dedicated to delivering life-changing oral therapies for people affected by rare diseases with significant unmet needs. The acquisition reflects Chiesi’s ambition to continue growing responsibly, investing in innovation, and building long-term value for patients, communities and future generations.

For more information visit www.chiesirarediseases.com.

Follow @ChiesiGlobalRareDiseases on LinkedIn, Facebook, Instagram, X and YouTube.

Chiesi Global Rare Diseases Media Contact
Sky Striar
LifeSci Communications
Email: sstriar@lifescicomms.com

References

1. FILSUVEZ^® (birch triterpenes) topical gel [prescribing information]. Chiesi USA, Inc.; 2024.
   
   
2. Denyer J, Pillay E, Clapham J. Best practice guidelines for skin and wound care in epidermolysis bullosa. An International Consensus. Wounds International, 2017
   
   
3. Fine JD. Inherited epidermolysis bullosa. Orphanet Journal of Rare Diseases 2010; 5(12): doi.org/10.1186/1750-1172-5-12.
   
   
4. Tabor A, Pergolizzi JV, Marti G, et al. Raising awareness among healthcare providers about Epidermolysis Bullosa and advancing toward a cure. J Clin Aesthet Dermatol 2017; 10(5): 36-48
   
   
5. Epidermolysis Bullosa Research Partnership. “What Is EB?” EB Research Partnership, https://www.ebresearch.org/what-is-eb.html
   

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