European Commission Approves IDELVION®, A long acting Hemophilia treatment using Albumedix Albumin-based Drug Delivery Technology12 May 2016
Albumedix™ proprietary VELTIS® drug delivery technology used in CSL Behring IDELVION® - now approved in the European Union
Copenhagen, Denmark – May 11, 2016 – Albumedix can now announce that the European Commission has approved IDELVION® [albutrepenonacog alfa]; an innovative, long-acting Factor IX/Albumin fusion enabled using Albumedix's VELTIS drug delivery platform.
The European approval of IDELVION comes only few months after its approval in the United States and Canada where Peter Rosholm, CEO Albumedix commented “The adoption of Albumedix’s VELTIS technology by CSL Behring marks a further milestone for our half-life extension platform. This announcement follows the successful use of the technology by GlaxoSmithKline in its TANZEUM® and EPERZAN® branded therapies for type 2 diabetes. We consider the authorization of IDELVION as further proof that VELTIS can offer true benefits to patients in the area of hemophilia, significantly reducing the discomfort, side-effects and inconvenience associated with frequent drug dosing.”
IDELVION can be used by all age groups (children and adults). The approved treatment regimen includes routine prophylaxis to prevent or reduce the frequency of bleeding episodes; on-demand control; and the perioperative management of bleeding (around the time of surgery). The application of Albumedix’s VELTIS technology in the drug delivers an extended half-life which will improve the lives of patients living with the condition by reducing the frequency of injections by up to once every 14 days.
VELTIS technology is a platform of native and engineered human albumins. When combined with a drug candidate it offers the potential for adaptive control of therapeutic half-life. The platform has the potential to significantly improve the treatment options available to hemophilia patients by maintaining the activity levels of therapeutics for prolonged periods and opening the door towards extended dosing intervals.
For further information on Albumedix’s VELTIS drug delivery platform, read more Here
Albumedix improves patient outcome with a range of albumin-based products and technologies that facilitate the development of superior biotherapeutics.
Albumedix develops albumin-based products and technologies for advanced drug and vaccine formulation, extended drug half-life and improved drug delivery. Our products and technologies are used in clinical and marketed drugs and out-licensed to pharmaceutical and biotech companies worldwide. With over 25 years’ experience in the biopharmaceutical industry, we have the scientific, technical and regulatory expertise needed to support companies in moving faster to market with superior biotherapeutics. We also use this expertise to strengthen our own drug pipeline. Albumedix is a global company and a fully owned subsidiary of Novozymes A/S. www.albumedix.com
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