The European Commission has approved InductOs (rhBMP-2/ACS) [recombinant human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge] for the treatment of single level (L4-S1) anterior lumbar spine fusions as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least six months of nonoperative treatment for this condition. InductOs has been approved by the European authorities since 2002 for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary nail fixation, Wyeth and Astellas BV jointly announced here.
Degenerative disc disease is a leading cause of lower back pain and one of the most prevalent health problems in the world. Nonoperative forms of treatment fail to provide sufficient relief from pain and disability for many patients. For them, fusion of the involved spinal segments, and often anterior lumbar interbody spine fusion using autogenous bone with interbody fusion cages, is considered a viable course of action.
"With InductOs, surgeons can now offer EU patients an alternative to painful autogenous bone harvesting," Joseph Camardo, medical director for Wyeth Pharmaceuticals North America said adding, "The potential benefit for the patient is relief from the symptoms of degenerative disc disease without the additional pain and morbidity associated with autograft harvesting."
InductOs contains recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, or dibotermin alfa), a recombinant version of a naturally occurring human protein that was discovered and developed by Wyeth Pharmaceuticals. The protein is manufactured at a Wyeth biopharmaceutical facility in Andover, Massachusetts.
Wyeth Pharmaceuticals and Astellas BV, a subsidiary of Astellas Pharma Inc., are partners in the development and commercialization of BMP products in Europe. Medtronic Sofamor Danek (MSD), the spinal business of Medtronic, has the exclusive promotion rights for InductOs in Europe for certain indications, including acute tibial fractures and spinal fusion.