Bayer Schering Pharma receives green light from European authorities to use Gadovist® 1.0 in children
Approval for indication extension for contrast medium
Berlin – Bayer Schering Pharma AG successfully completed the procedure for securing approval to use the contrast medium Gadovist® 1.0 in children aged seven and above in Europe’s main markets. Germany will start to introduce Gadovist® 1.0 for this new indication in January of this year. In addition, the Swiss Regulatory Authorities have approved Gadovist® 1.0 for the use in children aged 2 years and older.
“When it comes to drugs, children are not simply little adults. For this reason, we incorporated a new scientific approach within the study programme that helped us to substantially reduce the number of samples per child and the number of patients,” said Professor Hans Maier, Head of Diagnostic Imaging at Bayer Schering Pharma. “We are very pleased that we will soon be able to provide radiologists with our all-rounder Gadovist for use in children aged seven and older. We will cooperate with the authorities and will submit further data if requested with the prospect of securing approval for the use of Gadovist 1.0 in children under the age of seven in Europe’s main markets.”
Gadovist is approved for the most frequently conducted magnetic resonance tomography (MRT) examinations which are enhanced by contrast media. These include blood vessel imaging and examinations of the central nervous system, the liver and the kidney. Submission for approval for the paediatric indication is currently underway in all other countries in which Gadovist has been approved for adults.
The open multi-centre study, which was necessary for securing an indication extension for Gadovist, involved 140 children and adolescents aged 2 to 17 who were scheduled for a contrast-enhanced MRT scan. The study investigated the pharmacokinetics (distribution and excretion) as well as the safety and tolerability of Gadovist in young patients. It also undertook an assessment of imaging quality. It was shown that Gadovist is well-tolerated in this patient group too. The study also showed that the dosage recommendation based on body weight, which is routine in adults, can also be applied in the case of children.
Gadovist is a modern, highly efficient MRT contrast agent. It is approved for the contrast-enhanced MRT of various parts of the body, including the brain, the spinal chord, the liver, the kidney and the blood-vessel system. With its 1.0 mol/L concentration of gadobutrol, a stable macrocyclic gadolinium compound, Gadovist contains twice as much gadolinium per unit of volume as other extracellular contrast media available on the market. Moreover, Gadovist has a high T1-relaxivity in plasma. Due to its combination of high concentration and high relaxivity, Gadovist exhibits the highest T1-shortening per mL of all gadolinium contrast media. This results in excellent image quality and offers practical advantages in the case of smaller injection volumes. Gadovist was approved for the first time in 1998 and is now approved in over 50 countries.
About Bayer HealthCare
The Bayer Group is a research-based and growth-oriented global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the health care and medical products industry. The company combines the activities of the divisions, Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care. It is the aim of Bayer HealthCare to discover, develop, produce and market products that will improve human and animal health worldwide. For more information, please visit the website www.bayerhealthcare.com.
About Bayer Schering Parma
Bayer Schering Pharma is one of the world’s leading specialty pharmaceutical companies. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare. Bayer Schering Pharma attaches great importance to innovation and aims to be a market leader in specialized markets worldwide with innovative products. In this way Bayer Schering Pharma makes a contribution to medical progress and strives to improve people’s quality of life. For more information, please visit the website www.bayerscheringpharma.de.
This release may contain forward-looking statements based on current assumptions and forecasts made by the Bayer Group or sub-group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no obligation whatsoever to update these forward-looking statements or to adapt them to future events or developments.
This news content was configured by WebWire editorial staff. Linking is permitted.
News Release Distribution and Press Release Distribution Services Provided by WebWire.