- Approval is based on the SENSCIS® study which showed nintedanib slows the loss of pulmonary function in people living with systemic sclerosis-associated ILD (SSc-ILD)1
- Following the FDA’s approval in September 2019, nintedanib in SSc-ILD has so far been approved in 15 countries including Canada, Japan and Brazil
- Being the first and only approved treatment option available for people living with SSc-ILD, the approval constitutes a breakthrough in an area of high unmet need
INGELHEIM, Germany I April 21, 2020 I Boehringer Ingelheim today announced that the European Commission has approved nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults.2 The approval comes after the Committee for Medicinal Products for Human Use had adopted a positive opinion for nintedanib in treatment of SSc-ILD on 27 February 2020.
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 lead to life-threatening complications. When the lungs are affected, it can cause interstitial lung disease (ILD), known as SSc-ILD.1,6 ILD is a leading cause of mortality, accounting for almost 35% of SSc-related deaths.7
“This is a real breakthrough in the treatment of people living with SSc-ILD,” said Peter Fang, Senior Vice President and Head of Therapeutic Area Inflammation at Boehringer Ingelheim. ”Once fibrosis of the lungs occurs it cannot be reversed. Nintedanib, being the first and only approved treatment for SSc-ILD, is serving a high unmet need making a real positive difference to those living with this life-changing condition. The approval is a further milestone in Boehringer Ingelheim’s ongoing dedication for people living with pulmonary fibrosis.”
“The European Commission’s decision is very welcome news for the European scleroderma community,” commented Sue Farrington, President of the Federation of European Scleroderma Associations (FESCA). “When scleroderma affects the lungs, there can be severe consequences. The availability of a therapy option brings great hope to those living with scleroderma and their loved ones.”
The European Commission’s approval is 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 SSc-ILD.1 The primary endpoint was the annual rate of decline in forced vital capacity (FVC) assessed over a 52-week period. Results showed nintedanib slowed the loss of pulmonary function by 44% (41mL/year) relative to placebo, as measured in FVC over 52 weeks.1 Furthermore, results showed that nintedanib had a safety and tolerability profile similar to that observed in patients with idiopathic pulmonary fibrosis (IPF).1
Regulatory approvals for the treatment of patients living with SSc-ILD have also been granted in several countries including Canada, Japan and Brazil. Nintedanib is approved in over 75 countries for the treatment of IPF, and it is the first approved treatment for SSc-ILD.8
SENSCIS® Trial
SENSCIS® was the largest randomized controlled trial to be conducted in patients with SSc-ILD, involving 576 patients across more than 32 countries including the United States, Canada, China, Japan, Germany, France and the United Kingdom. The primary endpoint was the annual rate of decline in lung function as measured in FVC (mL/year) assessed over 52 weeks. The trial also collected data on other manifestations of the disease with key secondary endpoints identified as skin thickness as measured by absolute changes from baseline in modified Rodnan skin score (mRSS) and health-related quality of life measured by the total score on the St George’s Respiratory Questionnaire (SGRQ) at week 52. Enrolment criteria included a diagnosis of SSc with onset of first non-Raynaud symptoms within 7 years, ILD confirmed by high resolution computed tomographic that showed fibrosis affecting at least 10% of the lungs, at least 40% predicted FVC, and a diffusion capacity of the lung for carbon monoxide (DLco) as 30–89% predicted. Patients were randomized to receive nintedanib 150 mg twice daily or placebo. Patients on stable therapy with mycophenolate or methotrexate and/or taking prednisone up to 10 mg/day were allowed to participate.1
About systemic sclerosis-associated ILD
Systemic sclerosis-associated ILD is a chronic lung disease in which scar tissue (“fibrosis”) and/or inflammation builds up in the walls of the air sacs of the lungs in a person with a diagnosis of scleroderma.9 ILD is the leading cause of mortality in SSc, responsible for up to 35% of SSc-related deaths.7 The onset of SSc typically occurs at a young age, between 25 and 55 years, and ILD can develop early in patients with SSc, so regular screening is critical.6,10,11
Nintedanib
Nintedanib is a tyrosine kinase inhibitor targeting key receptors involved in signalling pathways that lead to pulmonary fibrosis.12 It is already approved in more than 75 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF) – a chronic and ultimately fatal disease characterized by a decline in lung function. It is estimated that over 80,000 people with IPF have been treated with nintedanib, and it is recommended for use in IPF patients by international guidelines.13
In September 2019, nintedanib was approved in the U.S. as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD8. Submissions have been made to other regulatory bodies across the globe and so far, regulatory approvals have been granted in Canada, Japan, Brazil and other countries.
Nintedanib has also been granted Breakthrough Therapy Designation by the FDA and received subsequent approval for the treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype in March 202014.
Boehringer Ingelheim
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.
As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.
We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.
More information about Boehringer Ingelheim can be found at www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.
Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
References
1 Distler O, et al. Nintedanib for systemic sclerosis-associated interstitial lung disease. N Eng J Med 2019;380:2518–28. Available at: http://dx.doi.org/10.1056/NEJMoa1903076. Last accessed April 2020.
2 European Summary of Product Characteristics Ofev®, approved April 17, 2020. Data on file.
3 Denton CP, Khanna D. Systemic sclerosis. Lancet 2017;390:1685–99.
4 Cottin V, et al. Interstitial lung disease associated with systemic sclerosis (SSc-ILD). Respir Res 2019;20:13.
5 Kowal-Bielecka O, et al. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis 2017;76:1327–1339.
6 Solomon JJ, et al. European Respiratory Update: Scleroderma lung disease. Eur. Respir. Rev. 2013; 22: 127, 6–19.
7 Tyndall AJ, et al. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database. Ann Rheum Dis 2010;69:1809–1815.
8 US Food and Drug Administration. Press release. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-rare-type-lung-disease. Last accessed April 2020.
9 Pulmonary Fibrosis Foundation. Scleroderma-associated interstitial lung disease (SSc-ILD). Available at: https://www.pulmonaryfibrosis.org/docs/default-source/disease-education-brochures/pf-fact-sheet-series—ssc-ild_digital.pdf?sfvrsn=ae99918d_2. Last accessed April 2020.
10 Scleroderma Foundation. What is scleroderma? Available at: http://www.scleroderma.org/site/PageNavigator/patients_whatis.html#.V%20hgSaPlViko. Last accessed April 2020.
11 Jaeger VK, Wirz EG, Allanore Y, et al. Incidences and risk factors of organ manifestations in the early course of systemic sclerosis: a longitudinal EUSTAR study. PLoS One. 2016;11(10):e0163894.
12 Ofev Summary of Product Characteristics. Available at https://www.ema.europa.eu/en/documents/product-information/ofev-epar-product-information_en.pdf (Date of latest renewal: 23 September 2019). Last accessed April 2020.
13 Raghu G, et al. An Official ATS/ERS/JRS/ALAT Clinical Practice Guidelines: Treatment of Idiopathic Pulmonary Fibrosis: Executive Summary. Am J Respir Crit Care Med. 2015; 192(2)238 – 248.
14 US Food and Drug Administration. Press release. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-group-progressive-interstitial-lung-diseases. Last accessed April 2020.
SOURCE: Boehringer Ingelheim
