U.S. Food and Drug Administration (FDA) Approves Recombinant Protein Treatment for Tibia Fractures
Wyeth's rhBMP-2/ACS Offers Potential for Improved Fracture Healing
"This unique protein represents a breakthrough in orthopedic surgery as it can help improve fracture healing, while reducing the chances of infection," says Joseph Camardo, M.D., Senior Vice President of Global Medical Affairs and Medical Director for Wyeth Pharmaceuticals North America. "It clearly represents a novel approach to orthopedic surgeons facing a serious tibia fracture."
Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, or dibotermin alfa), a recombinant version of a naturally occurring human protein, was discovered and developed by Genetics Institute, now part of Wyeth. The protein is manufactured at a Wyeth biopharmaceutical facility in Andover, Massachusetts.
In 2002, the European Commission approved the Marketing Authorization Application (MAA) for rhBMP-2/ACS for use in the treatment of acute tibia fractures in adults in the European Union (EU). Marketed under the name InductOs(TM), this product was introduced in the EU in July 2003.
Medtronic Sofamor Danek (MSD) will be marketing the product for tibia fractures, while purchasing the rhBMP-2 from Wyeth. Wyeth will receive royalties and milestone payments from MSD.
Most read news
Organizations
Other news from the department research and development
Get the life science industry in your inbox
By submitting this form you agree that LUMITOS AG will send you the newsletter(s) selected above by email. Your data will not be passed on to third parties. Your data will be stored and processed in accordance with our data protection regulations. LUMITOS may contact you by email for the purpose of advertising or market and opinion surveys. You can revoke your consent at any time without giving reasons to LUMITOS AG, Ernst-Augustin-Str. 2, 12489 Berlin, Germany or by e-mail at revoke@lumitos.com with effect for the future. In addition, each email contains a link to unsubscribe from the corresponding newsletter.