Bayer says strong clinical data helped Recothrom gain approval

The first approval of Recothrom is significant of the drug’s strong clinical data, it was stated today by pharmaceutical manufacturer Bayer.

Recothrom Thrombin is a plasma-free recombinant designed for use as a topical hemostatic product. This week it gained approval from the US Food and Drug Administration following the company’s acquisition of product rights for all non-US markets last year.

The drug is a form of human thrombin structurally similar to its real counterpart and according to the company, gives surgeons an option to provide patients with a plasma-free alternative during surgical hemostasis.

Hans Bishop, head of the global haematology/cardiology unit at Bayer, said the development is a “significant signal” of the product’s data.

“Recothrom is an attractive addition to our specialty pharmaceutical portfolio,” he added.

“Our partnership with ZymoGenetics demonstrates Bayer’s continued focus on working collaboratively with innovative biotechnology companies to develop and commercialise novel protein therapeutics.”

ZymoGenetics, which received the approval, is also currently overseeing the development of cancer drug Interleukin 21.