From the March 2015 issue of HealthCare Business News magazine


The other approval was for children below the age of two. Pering says, “One of the missing items in the U.S. was the approved use of contrast agents in these children, and Gadavist is now the first approved contrast for use with neonates going up to all age groups.”

“Those two major advances focused in the U.S. market where the regulatory landscape is slightly different, but in the U.S. that was big,” says Pering. For Bayer, CT contrast is a much bigger part of their international business than it is domestically. Bracco’s ultrasound agent, Lumason, was approved in October. For conducting ultrasound with contrast in the U.S., that means they’ve joined Lantheus, (with Definity) and GE Healthcare, (with Optison) as the primary players in that segment of the marketplace. Lantheus’ Definity is FDA approved for manufacturing by Jubilant HollisterStier, and now their SPECT/CT contrast agent, Neurolite, is also approved for manufacturing by that company. The timing for that approval will help the company ensure they have a steady supply of the contrast, which has recently been approved for use in Japan and Australia.


Lantheus reached a similar agreement with the Institute for Radioelements to manufacture Xenon 133, which is an inhaled contrast agent used for imaging the lungs and evaluating pulmonary function, and with SHINE Medical Technologies to supply Mo-99, which is for nuclear medicine.

Last November, Bracco announced FDA approval of a multi-dose compliant packaging of Isovue, an agent used with CT. There are certain benefits associated with packaging contrast agents differently.
Pharmacy bulk packages (PBPs) for multi-dose contrast agents were initially approved in the 1990s, but the Joint Commission began to crack down on the bulk packaging.

The approval of Bracco’s Isovue made it the only multi-dose compliant contrast medium in the U.S., which the company believes can allow for faster throughput, greater cost-effectiveness, and reduced contrast waste for CT imaging departments.

For Bayer, pre-filled syringes are a staple of their international product portfolio. “There is a trend towards pre-packaged syringes in some countries and markets,” says Pering, “That is not new to us; it has always been in our portfolio. In some markets there is a strong preference for various reasons — patient safety concerns, hygiene and sterility.”

Risk reduction challenges
In terms of radiation exposure, MR has certain patient advantages over CT, but the value of a good CT image often justifies the dose involved. For Pering, there is a somewhat analogous decision-making process when choosing whether or not to use a contrast agent, and which one to use.

March 2015 Magazine

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