The FDA has approved a label change to Bracco Diagnostics‘ MultiHance MRI contrast agent. The company’s product can now be used to visualize lesions with abnormal vascularity of the brain and spine in patients younger than two years old.
Data collected in pediatric patients under the age of two showed that a dose of 0.05 mmol/kg is effective at boosting the visualization of lesions in the brain and spine. Older kids and adults, however, need a dose of 0.1 mmol/kg.
“The approval of use of MultiHance in younger pediatric patients, including term neonates, reflects the review made by the Food and Drug Administration (FDA) of the safety and efficacy of MultiHance in that special patient population,” Dr. Alberto Spinazzi, SVP & head of global medical & regulatory affairs at Bracco Group, said in prepared remarks. “The FDA approval means that the benefit-risk ratio of MultiHance use in MRI of the CNS is positive also in neonates and infants, as it is in older subjects.”
“This approval is a testament of our commitment to provide new and expanded indications for this class of products, with special efforts aimed to benefit patients with this specialized need,” president & CEO Vittorio Puppo added.