Wyeth Pharmaceuticals, a division of Wyeth announced that the Orthopedic and Rehabilitation Panel of the U.S. Food and Drug Administration (FDA) Medical Devices Advisory Committee recommended FDA approve, with conditions, its application for the use of recombinant human bone morphogenetic protein-two (rhBMP-2) applied to an absorbable collagen sponge (ACS) to treat open long-bone fractures. The Panel's recommendation is not binding on the FDA.
In serious long-bone fractures, fracture healing sometimes develops slowly (delayed union) or does not occur at all (nonunion). Consequently, serious long-bone fractures can often require a second or third intervention to bring about healing, which diminishes a patient's ability to return to normal activity in a timely manner.
Treatment with rhBMP-2/ACS has the potential to stimulate bone growth at the fracture site where implanted, and may augment fracture healing in serious open long-bone fractures.
"The type of fracture that would be considered for treatment with rhBMP-2/ACS can be a major burden to a patient because of the time for healing and the frequent need for corrective follow-up surgeries," says Victoria Kusiak, M.D., vice president, Global Medical Affairs and North American Medical Director, Wyeth Pharmaceuticals. "The panel's decision today is supported by the data from the pivotal trial for rhBMP-2/ACS, which showed that rhBMP-2/ACS accelerated fracture healing and reduced the frequency of secondary interventions."
The data package submitted to the FDA included results from a pivotal trial in which patients with open tibial fractures were randomly assigned to be treated with standard of care (SOC) alone, SOC plus 0.75 mg/mL rhBMP-2 on an ACS, or SOC plus 1.50 mg/mL rhBMP-2 on an ACS. The 1.5 mg/mL dose was recommended for approval.
In clinical trials, rhBMP-2/ACS was generally well tolerated. In the pivotal Phase 3 clinical trial, there was a statistically greater incidence of numbness in the rhBMP-2/ACS 1.50 mg/ML group. In contrast, there was a statistically higher incidence of pain and hardware failure in the SOC group (patients who did not receive the rhBMP-2/ACS implant). Rates of other frequent adverse events were not statistically different among treatment groups; these events were associated with the patients' injuries and/or the reparative surgery.
Recombinant human BMP-2/ACS was discovered and developed by Wyeth. The European Commission has already approved the recombinant protein for use in the treatment of open tibial fractures. In the United States, rhBMP-2/ACS with an interbody fusion cage has also been approved for use by Wyeth's licensee, Medtronic Sofamor Danek, in the treatment of certain types of spinal degenerative disc disease, a common cause of low back pain.