DRAXIS seeks FDA market clearance for cardiac imaging product

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DRAXIMAGE has submitted an Abbreviated New Drug Application (ANDA) to the U.S. FDA for its generic kit for the preparation of Tc-99m Sestamibi for injection (DRAXIMAGE Sestamibi), a nuclear medicine imaging agent used in myocardial perfusion imaging (MPI) to evaluate blood flow to the heart in patients undergoing cardiac tests, the company said.

"This is our first product to be filed with the FDA among the near-term and medium-term new product opportunities that we identified as high priority growth drivers in our development strategy," said Jean-Pierre Robert, president of DRAXIMAGE. “We are now actively seeking opportunities to establish marketing and distribution partnerships for this product in North America and Europe."

Once the product is approved, DRAXIMAGE plans to enter the MPI market after the key patent for the currently marketed Tc99m Sestamibi product expires, which is expected to be in 2008 in the U.S. DRAXIMAGE also plans to file for marketing approvals elsewhere, including European countries, according to a release.

The sestamibi kit is used in nuclear medicine imaging to show how well the heart muscle is supplied with blood both at rest and during strenuous activity. The radioisotope Technetium-99m is attached to the sestamibi molecule forming Tc-99m Sestamibi. When injected into the bloodstream this radiopharmaceutical agent is distributed throughout the heart muscle in proportion to the blood flow received by various portions of the heart. Heart images are then obtained using a gamma camera that can detect the Technetium-99m. Two sets of images are typically taken, one while the patient is at rest and a second set while the patient is under stress, often by exercising on a treadmill or stationary bicycle. The resulting two sets of images are compared with each other to diagnose the presence of coronary heart disease by detecting areas of the heart that may not be receiving normal blood flow. This imaging technique is known as cardiac stress testing or myocardial perfusion imaging (MPI).