Bayer HealthCare receives EU label extension for Gadovist 1.0

Bayer HealthCare has completed a European variation procedure that will allow its imaging agent Gadovist 1.0 to be used in wider applications.

The EU label extension authorises the product for use in magnetic resonance imaging (MRI) of the whole body, including the brain and spine, head and neck region, lung, breast, abdomen, pelvis, kidney, extremities and musculoskeletal system, as well as blood vessels.

It also covers cardiac magnetic resonance imaging to diagnose coronary heart disease, with clinical trials now being carried out as Bayer HealthCare seeks further approvals in additional territories.

Using a combination of MRI scans and Gadovist 1.0, clinicians can produce detailed images of different organs without exposing the patient to ionising radiation.

Alan Main, head of Bayer HealthCare's medical care division, said: "This label extension strengthens Gadovist-enhanced MRI as a radiation-free diagnostic modality to identify the early onset of diseases."

Earlier this week, the company announced positive new clinical trial data for its drug Xarelto, showing its efficacy among acute coronary syndrome patients.