FDA approves Bayer's Gadavist® (gadobutrol) injection as the first magnetic resonance contrast agent for pediatric patients less than 2 years of age

  • Expanded use of Gadavist is specific to detecting and visualizing areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in pediatric patients under the age of 2 years
  • Approval based on data demonstrating the pharmacokinetic and safety profiles of Gadavist at standard dose (0.1 mmol/kg) were similar to adults and to children 2 years of age and older
  • U.S. Food and Drug Administration (FDA) granted priority review designation for Gadavist (gadobutrol) for this population

LEVERKUSEN, Germany I January 5, 2015 I Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use with magnetic resonance imaging (MRI) in pediatric patients less than 2 years of age, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. (1) Gadavist was previously approved for this use in patient populations over the age of 2. The FDA's priority review was based on a study showing that the pharmacokinetic (PK) and safety profiles in pediatric patients less than 2 years of age were similar to that of older children and adults at standard dose (0.1 mmol/kg). (2)

"Until this study, there were limited data regarding the use of gadolinium-based contrast agents in pediatric patients younger than 2 years of age, and there has been a significant need to better understand how they work in our youngest patients," said Dr. Ravi Bhargava, study investigator and pediatric radiologist, University of Alberta, Edmonton, Canada. "Ultimately, it's important for us to have safe and effective tools to help us accurately detect abnormalities and visualize areas of the central nervous system in children of all ages."

"Gadavist is the first FDA-approved gadolinium-based contrast agent for pediatric patients under 2 years of age, including term neonates, and the approval provides guidance to physicians on how to use Gadavist in these young patients," said Christiane Pering, Chief Medical Officer (CMO) and Head of Innovation within Bayer HealthCare's Medical Care division. "With this label expansion, Gadavist is appropriate to use for MRI of the central nervous system at a standard dose of 0.1mmol/kg for patients of all ages – term neonates to adults."

In the EU a respective supplemental application for Gadovist (trade name for Gadavist outside of the US) is currently undergoing regulatory review.

About Pharmacokinetics

Pharmacokinetics (PK) is the study of the movement of a drug in the body, including the process of distribution and elimination, and it is dependent on patient-related factors, as well as the drug's chemical properties.

About the Study

The study enrolled 47 pediatric patients with ages spanning from term neonates to 23 months with normal renal function from nine centers across the U.S., Canada and Europe. Forty-four pediatric patients were evaluated for safety and efficacy and 43 were eligible for a PK profile evaluation, including nine term neonates less than 2 months of age. (2)

The data showed that the Gadavist PK profile in pediatric patients under 2 was similar to the PK profile in older pediatric patients and adults. Investigators also observed a similar safety profile for Gadavist in this pediatric population. (2)

The study found that the Gadavist adverse event (AE) profile was consistent with what has been seen in older populations. In one patient, vomiting was reported as a mild adverse drug reaction (ADR) to Gadavist. The most common non-serious AEs unrelated to Gadavist were cough, nasopharyngitis, rhinitis, pyrexia and vomiting. Serious AEs were unrelated to Gadavist and were reported in three out of 44 patients. (2)

About Gadavist

Gadavist (gadobutrol) injection was first approved in the U.S. in March 2011 for intravenous use in diagnostic MRI in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Gadavist was further approved in June 2014 in the U.S. for MRI of the breast to assess the presence and extent of malignant breast disease.

Gadavist, also known as Gadovist® and Gadovist® 1.0 in other regions, is the U.S. brand name of the aqueous 1.0M solution of gadobutrol, a gadolinium (Gd)-based extracellular contrast agent for MRI with a macrocyclic structure. The safety profile of Gadavist has been established in clinical trials involving 6,330 patients.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.

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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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 liability whatsoever to update these forward-looking statements or to conform them to future events or developments.


1. Gadavist® (gadobutrol) Prescribing Information. Whippany, New Jersey, USA: Bayer Healthcare Pharmaceuticals, Inc.

2. Hahn G et al.; Open-label, Multicenter, Pharmacokinetic and Safety Study in Children Below 2 Years of Age Undergoing a Contrast-enhanced MRI with an Intravenous Injection of a Single Standard Dose of Gadobutrol. Abstract #SSM20-04. 2014 Radiological Society of North America (RNSA) Scientific Assembly and Annual Meeting, November 30 - December 5, 2014, Chicago, IL, USA, rsna2014.rsna.org/program/details/?emID=14008140 (Accessed January 3, 2015).

SOURCE: Bayer HealthCare