Bayer AG (ADR) (OTCMKTS:BAYRY) announced today that the FDA has granted a label expansion approval for the additional use of its drug, Gadobutrol (marketed in the US as Gadavist injections), for pediatric patients younger than 2 years of age (including term neonates), at the standard injection dose given to adults.
The injection was granted approval to be used with an MRI to find and sketch out the regions in a patient’s body with a disrupted blood-brain barrier and/or abnormal central nervous system blood vessels. The injection helps produce enhanced images, allowing the abnormalities to me analyzed more accurately.
“Gadavist is the first FDA-approved gadolinium-based contrast agent for pediatric patients under 2 years of age,” as mentioned by Christiane Pering, chief medical officer and head of innovation within Bayer HealthCare’s Medical Care division.
The drug received an FDA priority review after a study demonstrated that the pharmacokinetic (the movement and distribution of the drug in a body) and the safety profiles of the drug in patients younger than 2 years of age were similar to those in patients older than 2 years. 47 pediatric patients were enrolled in the study in 9 centers in the US, Europe, and Canada. The safety of the drug has been demonstrated in several clinical trials on 6,330 patients in total.
Dr. Ravi Bhargava, pediatric radiologist at the University of Alberta, said there is a great need for effective and safe treatments, as doctors need to detect the areas of abnormalities in pediatric patients’ bodies more accurately. Also, accurate images for the abnormal regions of the central nervous system in young patients need to be assessed by the treatments.
The MRIs enhanced by injecting patients with Gadavist have produced better images than the unenhanced MRIs.
Gadavist was originally approved in the US by the FDA for the same treatment in patients older than 2 years of age in March 2011, to help produce enhanced MRIs to locate vascular abnormalities. Furthermore, the injectable drug was approved in June 2014 for the MRI of breasts to locate malignant breast diseases, including breast cancer. About 40,000 women died of breast cancer in the US in June 2013.
A supplemental application for Gadovist – the name used for Gadavist outside US – is currently under review by the regulatory authorities in the EU.