Wyeth Pharmaceuticals has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the ReFacto Antihemophilic Factor (Recombinant) R2 Kit, the first needle-less reconstitution device with a prefilled diluent syringe for hemophilia.
ReFacto is a recombinant factor VIII product formulated without human serum albumin in its final formulation.
Compared with the previous method for reconstituting ReFacto, the R2 kit provides a faster and simpler infusion process. The R2 kit contains a syringe prefilled with diluent, a vial adapter, and a single-use vial of ReFacto containing either 250, 500, 1000, or 2000 IUs. The adapter is placed on the vial of ReFacto, and the adapter and prefilled syringe allow ReFacto to be reconstituted without the risk of needle exposure. The R2 kit is provided in a smaller package and has fewer components, reducing required storage space.
“The ReFacto R2 kit, with its simpler and faster infusion process and fewer components will enable ReFacto patients to spend less time infusing and more time living their lives,” said Dr. Gary L. Stiles, Executive Vice President and Chief Medical Officer of Wyeth Pharmaceuticals.
Wyeth anticipates that the ReFacto R2 Kit – R2 stands for Rapid Reconstitution -- will be available in the 4th quarter of 2004.
“At Wyeth, we are committed to the hemophilia community, and we continue to look for ways to improve lives through innovation. The ReFacto R2 Kit is the latest example of our commitment to providing tools that allow patients and their families to more conveniently incorporate hemophilia treatment into their everyday lives,” said Dr. Stiles.
Hemophilia A is a rare, inherited blood clotting disorder for which there is no cure. People with hemophilia A are deficient in the key protein (factor VIII) that is vital in the clotting cascade to prevent bleeding. Hemophilia A is characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. In the United States, between 15,000 and 17,000 people have hemophilia A.
ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical and short-term routine prophylaxis in patients with hemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown. As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tiredness, or symptoms of allergic reactions. The remote possibility exists for hypersensitivity to non-human mammalian proteins.