GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the European Commission (EC) has granted marketing authorisation for Benlysta®(belimumab) 10mg/kg as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE), with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy1.
"The European approval of Benlysta represents a significant milestone, and we are very pleased to be able to provide physicians an additional therapeutic option for treating appropriate patients with this chronic disease," said Dr Tony Hoos, Senior VP, European Medical Affairs, GSK.
"We and GSK are committed to making Benlysta available in countries worldwide," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "We are particularly honoured to be bringing this medicineforward in Europe, where a number of key academic research institutions were very important to its clinical development."
The European summary of product characteristics (SmPC) lists patient groups which have not been studied with belimumab, including severe active CNS lupus or severe active lupus nephritis. Use of belimumab is therefore not recommended to treat these conditions. Caution should be exercised if belimumab is co-administered with other B cell targeted therapy or cyclophosphamide, as it has not been studied in combination with these agents.
About Benlysta (belimumab)
Belimumab received approval from the U.S. Food and Drug Administration (FDA) on 9th March 2011. GSK and HGS announced approval from Health Canada on 12th July 2011. Regulatory applications have been submitted and are currently under review in Australia, Switzerland, Russia, Brazil, the Philippines, Israel, Singapore, Taiwan and Colombia.
Detailed recommendations for the use of belimumab are described in the SmPC, which will be published in the European public assessment report (EPAR, http://www.emea.europa.eu).
About the GSK/HGS collaboration
HGS and GSK are developing belimumab under a definitive co-development and co-commercialisation agreement entered into in 2006. Under the agreement, HGS had responsibility for conducting the belimumab Phase III trials, with assistance from GSK. The companies share equally in Phase III/IV development costs, sales and marketing expenses, and profits of any product commercialised under the current agreement.
Benlysta is a registered trademark owned by Human Genome Sciences, Inc., used under licence by the GlaxoSmithKline group of companies.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease.
Human Genome Sciences exists to place new therapies into the hands of those battling serious disease. For more information about HGS, please visit the Company's web site at www.hgsi.com. HGS, Human Genome Sciences and Benlysta are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.