Bayer submits recombinant human thrombin for EU approval
3 September 2008 00:00 in Pharmaceutical Company Product News
Bayer has announced the submission of recombinant human thrombin (thrombin alfa) to the European Medicines Agency for approval as a topical aid to control surgical bleeding.
The company said the compound is being commercialised in partnership with ZymoGenetics as part of a deal initiated in June 2007.
Under the terms of the agreement, Bayer has the global rights to the compound for all regions outside the US, with ZymoGenetics retaining these rights.
The product received regulatory approval from the US Food and Drug Administration (FDA) in January 2008 and is currently marketed as Recothrom, while Bayer plans to use this name wordlwide on receipt of regulatory approval.
"The biotechnologically produced recombinant thrombin alfa provides surgeons with a plasma-free thrombin alternative for surgical haemostasis," Bayer said.
It added that, because it is not derived from human or animal blood, the drug does not have the same risk of infections usually associated with plasma products.
As it is not derived from animal or human blood, it does not imply the risk of infections which is generally associated with plasma products.
In January 2008, Bayer said the FDA approval of recombinant human thrombin highlighted the strong clinical data for the product.
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