Bayer Schering Pharma “fully convinced” of rivaroxaban success

Bayer Schering Pharma is “fully convinced” of the positive risk-benefit profile of rivaroxaban, the company has stated.

The organisation made its comments as it announced that its partner Ortho-McNeil does not think it will be able to submit its complete response to the Food and Drug Administration (FDA) until the final quarter of 2009.

It said that this would be the earliest possible period of time for the response to be submitted.

Kemal Malik, member of the Bayer HealthCare executive committee and chief medical officer, said that the company wants to take enough time to “diligently respond” to all of the feedback provided by the FDA.

“We are fully convinced of the positive risk-benefit profile of rivaroxaban, which has been approved in more than 60 countries worldwide in its first indication,” he added.

Earlier this month, Bayer Schering Pharma announced positive data on a global study relation to the positron emission tomography tracer florbetaben.