Pharmacy Daily | Bayer sells Trasylol

BAYER Healthcare has signed an agreement with Nordic Group, which will acquire its Trasylol (aprotinin injection) worldwide excluding in the USA. Under the deal Nordic will become the Marketing Authorization Holder for aprotinin in the relevant territories. The move follows a European Medicines Agency recommendation that marketing authorisation for aprotinin be reinstated in the EU. Aprotinin is an antifibrinolytic medicine which is indicated for prophylactic use to reduce blood loss and blood transfusion in adult patients undergoing isolated cardiopulmonary bypass surgery. It was withdrawn from the market in 2007 based on the results of a study of its costs and benefits - and now the EMA says the research was unreliable. Since 2007 both Nordic (which was already marketing an aprotinin product) and Bayer have maintained compassionate limited access programs in 16 countries, and last Sep the product’s marketing authorisation was also reinstated in Canada.

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