- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Orphan drug designation granted to Boehringer Ingelheim’s systemic sclerosis drug
13 September 2016 • Author: Niamh Louise Marriott, Digital Content Producer
The European Commission (EC) and US Food and Drug Administration (FDA) have both granted orphan drug designation to Boehringer Ingelheim’s nintedanib for the treatment of systemic sclerosis (SSc, also known as scleroderma), including the associated interstitial lung disease (SSc-ILD).
Senscis is specifically evaluating nintedanib to understand the disease process and potential benefit of the compound to treat SSc-ILD.
Systemic sclerosis, commonly referred to as “scleroderma,” is a disfiguring, disabling and potentially fatal rare disease that can cause scarring of the skin, lungs (SSc-ILD) and other organs. Worldwide an estimated 1 in 3000 people have systemic sclerosis3 (scleroderma) and up to 90% may develop some degree of lung scarring. SSc-ILD accounts for 35 percent of all disease-related deaths.
“Scleroderma and associated interstitial lung disease have a devastating impact on the patient community, and we welcome this important news that a potential new treatment has received orphan drug designation. It’s a crucial step forward in helping to address an unmet need and represents important progress for patients with this rare disease,” said Joep Welling, Federation of European Scleroderma Associations (FESCA aisbl).
“The Orphan Drug Designation granted by both the European Commission and FDA for nintedanib is an important milestone in the development of much needed therapies for the various complications of scleroderma” said Dr William Mezzanotte, Therapeutic Area Head, Respiratory Medicine at Boehringer Ingelheim.
“The need for treatment options for people with SSc-ILD is significant, and the SENSCISTM trial is an important first step in exploring the benefit of nintedanib in addressing the complications of scleroderma.
The success of nintedanib in treating IPF, in both clinical trials and the clinical world, along with similarities of IPF to other fibrotic lung diseases, including SSc-ILD, gives us great hope that this important medicine can help patients with SSc-ILD.”
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics