Stryker's OP-1 passes European hurdle

Stryker Corp's OP-1 (osteogenic protein 1) has been recommended forapproval by the European Union's Committee for Proprietary Medicinal Products, setting the product up to become the first biological product to be registered for orthopedic medicine in the EU. OP-1 is licensed to Stryker by Curis and is also under regulatory review in the USA and Australia.

OP-1 is under review for the treatment of non-union of breaks in the tibia bone, of at least nine months' duration, secondary to trauma in skeletally-mature patients. The product is intended for use in cases where a previous treatment with a bone autograft has failed, or the use of an autograft is unfeasible. It acts via the initiation of bone formation through the induction of differentiation in mesenchymal cells, leading to the formation of chondroblasts and osteoblasts, and is administered by direct surgical placement.