FDA Approves First Spray-Dried Biologic

On April 30, 2015, FDA approved a novel biologic for the control of mild to moderate bleeding in adults during surgery, developed by ProFibrix BV and manufactured through Nova Laboratories’ aseptic spray-drying technique. The drug, Raplixa, is a blend of spray-dried thrombin and fibrinogen that is mixed and filled aseptically. Prior to being blended, the drugs are purified separately to reduce the risk for the transmission of blood-borne viruses. SeekingAlphareports that the human-derived thrombin and fibrinogen will be supplied by Australia-based company CSL Behring.

“The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, in an FDA press release. “This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature.” In addition, this means that the ready-to-use Raplixa does not require thawing before use. The product can be applied directly from the vial or with a low-pressure spray applicator device (RaplixaSpray), also from Nova Laboratories. Raplixa may have advantages over other fibrin sealants on the market, as it does not require cold-chain transportation and has no special storage requirements related to temperature.

Raplixa was tested in a Phase III clinical study involving 719 participants in four countries during a period of 11 months in a variety of different surgical procedures. When compared to an absorbable gelatin sponge alone to control bleeding, Raplixa, in combination with a sponge, was shown to be more effective for the formation of blood clots.

“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 stabilization technology,” said Nova spokesperson, Sam de Costa, in a press release. Nova is in the process of constructing a new commercial spray-drying facility for the discovery, development, and commercial manufacture of spray-dried medications. The facility is expected to be operational in 2017.

Sources:
FDAThe Medicines Company