- 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
MAA submitted for haemophilia A treatment, Adynovi
2 March 2016 • Author: Victoria White
Baxalta has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for approval of Adynovi, an extended circulating half-life recombinant Factor VIII (rFVIII) treatment, for paediatric, adolescent and adult patients with haemophilia A and for use during surgery.
Currently licensed in the US as Adynovate [Antihemophilic Factor (Recombinant), PEGylated] and under regulatory review in Japan, Canada and Switzerland, Adynovi is the only rFVIII treatment for haemophilia A developed based on the demonstrated efficacy of Advate [Antihemophilic Factor (Recombinant)].
Adynovi is built on the full-length Advate molecule, a leading treatment for haemophilia A. The therapy leverages proprietary PEGylation technology designed to extend the amount of FVIII available for use in the body. The technology was selected because it maintains the integrity of the parent molecule (Advate) and reduces the time at which the body clears Adynovi, resulting in an extended circulating half-life. This proprietary technology has been used for more than 15 years in a number of approved medicines that treat chronic or serious conditions.
MAA based on data from three Phase III trials of Adynovi
Commenting on the announcement, Brian Goff, executive vice president and president, Haematology, Baxalta, said: ”We are dedicated to bringing Adynovi to haemophilia A patients all over the world. As we build on our market-leading portfolio of direct factor replacement treatments, we continually bring new options to haemophilia patients, empowering them to manage their haemophilia, with their caregivers, in the way that works best for them.”
The EMA filing is based on data from three Phase III clinical trials. Adynovi was studied in patients aged 12 to 65 years, in a prospective, global, multi-centre, open label, non-randomised study; in patients 12 years of age and younger, in a prospective, uncontrolled, open-label, multi-centre study; and for the perioperative control of haemostasis among 15 patients with severe haemophilia A undergoing surgical procedures.
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 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 L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. 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