- 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
CHMP recommends approval of isavuconazole in the EU
27 July 2015 • Author: Victoria White
Basilea has announced that the CHMP adopted a positive opinion recommending the approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis for whom amphotericin B is inappropriate.
Invasive aspergillosis and mucormycosis are life-threatening fungal infections predominantly occurring in cancer and other immunocompromised patients.
“Today’s positive CHMP opinion is a major step forward in making isavuconazole available in Europe for patients suffering from serious invasive fungal infections. Invasive aspergillosis and mucormycosis are life-threatening infections predominantly affecting cancer and other immunocompromised patients and are associated with high morbidity and mortality. We are committed to bring innovative treatments to patients with high medical need and look forward to the European Commission’s decision in the coming months,” said Ronald Scott, Basilea’s Chief Executive Officer.
Commenting on the CHMP’s opinion, Professor Johan A. Maertens, Department of Haematology, University Hospital Gasthuisberg, Belgium has highlighted the urgent need for new drugs in treating patients with invasive fungal infections, stating that, “morbidity and mortality associated with invasive fungal infections remain unacceptably high. Isavuconazole has shown promising results in the treatment of invasive mould infections and, if approved, has the potential to offer a new treatment option to patients suffering from these serious conditions.”
The European Commission (EC) will now review the CHMP’s positive opinion for isavuconazole.
Positive CHMP opinion bases on results from two Phase 3 clinical studies of isavuconazole
The positive CHMP opinion is based on results from the isavuconazole development programme. The safety and efficacy profile of isavuconazole in adult patients with invasive aspergillosis was demonstrated based on data from two phase 3 clinical studies: SECURE, a randomised, double-blind, active-control study in 516 patients with invasive aspergillosis, and VITAL, an open-label non-comparative 146-patient study of isavuconazole in renally impaired patients with invasive aspergillosis, or in patients with invasive fungal disease caused by other emerging fungi.
In the SECURE study, isavuconazole was non-inferior to voriconazole based on the primary endpoint of all-cause mortality at Day 42 in the intent-to-treat population.
The safety and efficacy profile of isavuconazole in patients with mucormycosis was demonstrated based on data from the VITAL study, which included a subpopulation of 37 patients with mucormycosis. All-cause mortality at Day 42 was 38% which is similar to mortality rates reported in literature for the treatment of mucormycosis. The efficacy of isavuconazole for the treatment of mucormycosis has not been evaluated in concurrent, controlled clinical trials.
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