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Trasylol wins continued US marketing authorisation

The FDA discusses the risk /benefit profile of Bayerís intravenous blood loss control drug Trasylol and agrees to continued US marketing authorisation

The Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to the FDA have held a meeting to discuss the risk /benefit profile of Bayerís intravenous drug Trasylol (aprotinin), which is used in coronary artery bypass graft (CABG) surgery.

Based on the Trasylol data in Bayer's controlled clinical studies and considering data from observational studies and public testimony presented at the meeting, the committees recommended that US marketing authorisation for Trasylol should continue.

Both committees also recommended that Bayer amend the US product label for Trasylol to provide additional prescribing guidance to doctors and also suggested that the German company conduct further clinical studies to assess the risks and benefits of Trasylol.

Trasylol is currently the only drug approved by the FDA for prophylactic use to reduce perioperative blood loss and blood transfusions in patients undergoing cardiopulmonary bypasses in the course of coronary artery bypass graft surgery, who are at an increased risk for blood loss and blood transfusion.

Q2 FY07 sales of Trasylol declined 18.4 per cent after two separate observational studies reported a possible correlation between the administration of Trasylol and myocardial infarction and stroke.

In Q2 FY07, sales of Bayerís haematology/ cardiology business unit rose EUR 19m to reach EUR 271m, compared with Q2 FY06 sales of EUR 252m. This represented an increase of 17.6 per cent after adjusting for currency and portfolio effects.

30th September 2008

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