Astellas/Wyeth's InductOs OK'd in EU for degenerative disc disease

The European Commission has approved Japan-based Astellas' Dutch subsidiary Astellas BV and US drugmaker Wyeth's InductOs (recombinant human bone morphogenetic protein-2/absorbable collagen sponge) for the treatment of single-level anterior lumbar spine fusions as a substitute for autogenous bone graft in adults with degenerative disc disease with at least six months of non-operative treatment.

"With InductOs, surgeons can now offer EU [European Union] patients an alternative to painful autogenous bone harvesting," commented Joseph Camardo, senior vice president of global medical affairs and medical director for Wyeth Pharmaceuticals North America. "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," he added.

Clearance was based on the results of a randomized, multicenter, 279-patient clinical trial, which demonstrated that, at 24 months post-operation, predetermined overall success, pain and disability and radiologic fusion were comparable between the InductOs group and patients treated with autologous bone fusion.