Raplixa has been approved by the US Food and Drug Administration
Nova Laboratories has welcomed the US FDA’s approval of Raplixa from ProFibrix, a Netherlands-based wholly owned subsidiary of The Medicines Company.
Raplixa is manufactured at Nova Laboratories sterile manufacturing facilities in the UK and consists of spray dried thrombin and fibrinogen, which are blended and filled aseptically.
Nova Laboratories has pioneered aseptic spray drying since introducing the world’s first aseptic spray dryer in 2008. The company is currently constructing a new commercial spray drying facility, planned to come on line in 2017, and will be able to offer a full spray drying service to customers from discovery, development through to commercial supply.
The FDA has approved the Raplixa fibrin sealant and the Raplixa spray device to provide adjunctive haemostasis for mild to moderate bleeding in adults in surgery.
Raplixa needs no thawing, reconstitution or mixing and can be applied directly from the vial or with the device, a low-pressure spray applicator, to the bleeding site where it dissolves in the blood, starting a reaction between two proteins, leading blood clots to form to help stop bleeding.
'This approval provides surgeons with an additional option to help control bleeding during surgery when needed,' said Karen Midthun, Director of the FDA’s Center for Biologics Evaluation and Research. 'The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature.'
The FDA approval was based on a large phase III multicentre clinical trial involving 721 patients in four countries in different surgical procedures. The Raplixa clinical supplies were manufactured by Nova.
Nova’s spokesman, Sam de Costa, said: 'Other companies exploring aseptic spray drying as a manufacturing option will see the FDA verdict as a regulatory milestone and a vote of confidence in this enabling stabilisation technology. We are thrilled to be part of another successful innovative drug presentation success story and to be manufacturing commercial supplies of Raplixa.'