New Spine Fusion Indication for Recombinant Protein Treatment

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New Spine Fusion Indication for Recombinant Protein Treatment

19 Apr 2005 Medical News Today

Wyeth and Astellas BV, today announced that 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.

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, " said ph Camardo, M.D.,

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. "

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.

The EMEA approval was based on data from a randomized multicenter

study of 279 patients undergoing an open anterior lumbar fusion

procedure. At 24 months postoperation, results in terms of

predetermined overall success, pain and disability, and radiologic

fusion were comparable between the patient group treated with

InductOs and the patient group treated with autologous bone fusion.

Like all medicines, InductOs may have side effects. The undesirable

effects observed in anterior lumbar spine fusion patients were

generally representative of the morbidity associated with spine

fusion using autogenous bone graft taken from the iliac crest. Very

common (>10 percent) undesirable effects such as accidental injury,

neuralgia, back pain and bone disorder, were similar in both control

and InductOs treatment groups. In spinal fusion studies 0.7 percent

of patients receiving InductOs developed antibodies to rhBMP-2 vs.

0.8 percent of patients receiving bone grafts; in addition 19 percent

of patients receiving InductOs developed antibodies to bovine Type I

collagen vs. 13 percent of patients receiving autogenous bone graft.

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 (NYSE: MDT), has the exclusive promotion rights

for InductOs in Europe for certain indications, including acute

tibial fractures and spinal fusion.