BOEHRINGER-INGELHEIM
Boehringer Ingelheim today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting marketing authorisation for nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults.1 In September, the U.S. Food and Drug Administration (FDA) approved nintedanib as the first and only medicine to slow the rate of decline in pulmonary function in adults living with SSc-ILD. Regulatory approvals for the treatment of patients living with SSc-ILD have also been granted in other countries including Canada, Japan and Brazil.
Systemic sclerosis (SSc), also known as scleroderma, is a disfiguring, disabling and potentially fatal rare autoimmune disease.3,4,5 It causes scarring (fibrosis) of various organs, including the lungs, heart, digestive tract and kidneys and can have life-threatening complications. When SSc affects the lungs, it can cause interstitial lung disease (ILD), known as SSc-ILD.2,6 ILD is the leading cause of mortality in SSc, accounting for almost 35% of SSc-related deaths.7
“SSc-ILD is a life-changing disease. Once fibrosis of the lungs occurs it cannot be reversed, and this can have a devastating impact on a patient’s life and daily activities” said Peter Fang, Senior Vice President and Head of Therapeutic Area Inflammation at Boehringer Ingelheim. “Striving to improve the lives of people living with pulmonary fibrosis, we are pleased with the Committee’s positive opinion, which represents an important step forward in helping to slow down the progression of this rare and life-changing disease.”
The positive opinion was based on the results of the SENSCIS® trial, a phase III, double-blind, placebo-controlled trial conducted to investigate the efficacy and safety of nintedanib in patients with ILD-associated systemic sclerosis (SSc-ILD).2 The primary endpoint was the annual rate of decline in Forced Vital Capacity (FVC) assessed over a 52-week period. Patients remained on the study treatment for at least 52 weeks of treatment or for a maximum of 100 weeks of treatment. Results showed nintedanib slowed the loss of pulmonary function by 44% (41mL/year) relative to placebo, as measured in FVC over 52 weeks.2 The adverse-event profile of nintedanib was similar to that observed in patients with idiopathic pulmonary fibrosis, with the most common adverse event being diarrhoea.2
~ENDS~
Please click on the link for ‘Notes to Editors’ and ‘References’: https://www.boehringer-ingelheim.com/press-release/chmpopinionnintedanibssc-ild
View source version on businesswire.com: https://www.businesswire.com/news/home/20200228005212/en/
About Business Wire
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
CapVest and Parquest Agree Terms on IPN’s Acquisition of Sopral8.7.2025 10:00:00 CEST | Press release
Inspired Pet Nutrition (“IPN”), the fast-growing pet food company controlled by CapVest Partners LLP (“CapVest”), and Parquest, a leading investment firm, have agreed terms on the acquisition of Sopral, a prominent branded pet food platform serving the European market, with manufacturing operations based in France. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250708134461/en/ Sopral products The transaction is subject to customary regulatory approvals and closing conditions. Financial terms have not been disclosed. Based in Pléchâtel, Brittany, France, Sopral is a leading manufacturer of branded premium dry petfood with a comprehensive range of high-quality nutritional solutions, including Pro-Nutrition Prestige, Pure Life and Protect brands. Sopral has a strong footprint and reputation in France and a fast growing online and international market presence in over 50 countries around the world. Employing over 130 people, th
Thales Reinforces its Leadership in eSIM and IoT Connectivity with a ‘Ready to Use’ Certified Solution8.7.2025 08:00:00 CEST | Press release
At a time when billions of connected objects are reshaping industries, Thales has achieved an essential security certification for its eSIM solution, reinforcing its leadership in trusted connectivity management for the Internet of Things (IoT). The certification, granted by the GSMA under the eSIM Security Assurance (eSA) scheme, marks a significant milestone in enabling large-scale, secure, and efficient IoT deployments across industries including smart metering, healthcare, and automotive. This positions Thales as a trusted partner capable of providing full protection against advanced cyber threats — delivering end-to-end security solutions, from chip to cloud, and ensuring compliance with emerging security standards (e.g., the EU Cyber Resilience Act). With over 5.8 billion IoT cellular connections expected globally by 2030 (GSMA Intelligence), businesses and industries face growing pressure to deploy connected devices at scale — securely and efficiently. The SGP.32 IoT specificati
Invivoscribe Expands Flow Cytometry Services to Accelerate CAR-T Immunotherapy Development and Regulatory Readiness with the Initiation of CERo Therapeutics Phase 1 Clinical Trial8.7.2025 06:00:00 CEST | Press release
Invivoscribe Inc., a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to support CERo Therapeutics Holdings, Inc., an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms. Through this collaboration, LabPMM (Invivoscribe’s global reference laboratories) have customized their multiparametric flow cytometry (MFC) services and implemented their sensitive MFC AML MRD assay to supportCERo’s clinical trial of its lead compound, CER-1236. The trial targets Acute Myeloid Leukemia (AML) in patients who are relapsed/refractory, in remission with MRD, or newly diagnosed with TP53-mutated MDS/AML. AML is an aggressive blood cancer characterized by the rapid accumulation of abnormal myeloid cells in the bone marrow and blood, disrupting normal hematopoiesis.1 Treating AML is especially complex due to its genetic heterogeneity and the high risk of relapse. CAR-T (chime
Tigo Energy Adds Solar-Plus-Storage Portfolio in Czech Republic to Build on MLPE Success8.7.2025 06:00:00 CEST | Press release
Successful PPDS P4 protocol certification opens full range of three-phase Tigo EI Inverters and the EI Residential product suite for grid connection in second-strongest E.U. market for Tigo. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced that the Company’s entire portfolio of three-phase Tigo EI Inverters has successfully passed the certification tests for compliance with the PPDS P4 requirements in the Czech Republic. Compliance with PPDS P4, formally known as Distribution System Operation Rules, Annex 4, is a prerequisite for grid connection of solar inverters in the Czech Republic, validating the compatibility with the technical conditions defined by the European Commission and adopted by local utility companies. In the wake of the proliferation of rapid shutdown requirements across Europe, with installers in the Czech Republic deploying nearly 107MW of Tigo MLPE in 2024, Tigo products ha
Murata Launches World’s First High-Frequency Filter Using XBAR Technology for 5G, Wi-Fi 7, and Future 6G Networks8.7.2025 04:00:00 CEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has announced the mass production and commercial shipment of the world’s first*1 high-frequency filter using XBAR technology*2. Developed by combining Murata’s proprietary Surface Acoustic Wave (SAW) filter expertise with XBAR technology from Murata's subsidiary Resonant Inc., it enables the extraction of desired signals while achieving both low insertion loss and high attenuation. These features are critical for the latest wireless technologies, including 5G, Wi-Fi 6E, Wi-Fi 7, and emerging 6G technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250707682186/en/ [Murata Manufacturing Co., Ltd.] The world’s first high-frequency filter using XBAR technology The demand for reliable high-frequency communications continues to grow in response to the widespread deployment of 5G and the future development of 6G. Simultaneously, wireless local-area network (W
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