- 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
Roche’s IPF drug Esbriet approved in Switzerland
23 September 2015 • Author: Victoria White
Swissmedic, the Swiss licensing and supervisory authority for therapeutic products, has approved Roche’s Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).
IPF is an ultimately fatal disease in which progressive scarring (fibrosis) of the lungs makes breathing difficult and prevents the heart, muscles and other vital organs from receiving enough oxygen. The disease can advance quickly or slowly, but after a time the lungs will harden and finally stop working altogether.
“This is an important day for patients who have to live with this insidious disease,” said Professor Malcolm Kohler MD, Head of the Department of Pulmonology at Zurich University Hospital. “With the approval of Esbriet in Switzerland, patients with IPF have a medicine that may slow the progression of the disease.”
Ebriet showed delayed progression of IPF in studies
The approval of Esbriet is based on data from a large, placebo-controlled Phase III study (ASCEND) and is supported by two other large Phase III trials (known as CAPACITY 1 and 2). In the ASCEND study, significantly more patients who received Esbriet showed delayed progression of the disease – corresponding to preservation of lung function – than those who received placebo.
Pooled analysis of the ASCEND and both CAPACITY Phase III trials also showed a 48% reduction in all-cause mortality at one year, as well as a 68% reduction in IPF-related mortality in the Esbriet group compared to placebo.
Esbriet was granted marketing authorisation in the European Union (EU) in 2011 for the treatment of adults with mild to moderate IPF in all 28 EU member countries, and has since also been approved in Norway, Iceland and Canada. In October last year, the US Food and Drug Administration (FDA) approved Esbriet under the Breakthrough Therapy Designation programme. In the same month, the EU Committee for Medicinal Products for Human Use (CHMP) recommended an update to Esbriet’s European product information in idiopathic pulmonary fibrosis, confirming the benefit of the product in terms of mortality rate and its favourable safety profile.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV 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) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics