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Cardiology Draxis radiopharmaceuticals division applies to FDA to market cardiac imaging product
Cardiology Draxis radiopharmaceuticals division applies to FDA to market cardiac imaging product
Draxis radiopharmaceuticals division applies to FDA to market cardiac imaging product
Monday, 29 November 1999 19:00 | 
| Specialties - Cardiology |
Draximage has submitted an Abbreviated New Drug Application (ANDA) to the FDA for its generic kit for the preparation of Tc-99m Sestamibi for injection.
Draximage, the radiopharmaceutical division of Draxis Health Inc., has submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for its generic kit for the preparation of Tc-99m Sestamibi for injection, a nuclear medicine imaging agent used in myocardial perfusion imaging (MPI) to evaluate blood flow to the heart in patients undergoing cardiac tests.
"The filing of this ANDA for Draximage Sestamibi is a significant milestone event that fulfills the commitment we made in March 2006 to aggressively pursue myocardial perfusion imaging," said Jean-Pierre Robert, President of Draximage. "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. The unique combination of product development expertise, research skills, and production capabilities at Draximage has contributed to the success to date of the sestamibi project. We are now actively seeking opportunities to establish marketing and distribution partnerships for this product in North America and Europe."
According to AMR/Arlington Medical Resources, in 2005 there were more than 7 million cardiac studies conducted in the US out of a total of over 15 million nuclear medicine procedures; making MPI the most widely performed nuclear medicine scan. Recent market research indicates that existing MPI products generate revenues in excess of $500 million annually in the US and that the imaging agent most often used in conducting MPI procedures is sestamibi labeled with the radioactive isotope Technetium-99m (Tc-99m Sestamibi).
Once its 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 for the United States. Draximage also plans to file for marketing approvals in other jurisdictions, including European countries.
Cardiac imaging with Tc-99m Sestamibi
The sestamibi kit is used in nuclear medicine imaging to show how well the heart muscle (myocardium) is supplied with blood (perfused) 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).
"The filing of this ANDA for Draximage Sestamibi is a significant milestone event that fulfills the commitment we made in March 2006 to aggressively pursue myocardial perfusion imaging," said Jean-Pierre Robert, President of Draximage. "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. The unique combination of product development expertise, research skills, and production capabilities at Draximage has contributed to the success to date of the sestamibi project. We are now actively seeking opportunities to establish marketing and distribution partnerships for this product in North America and Europe."
According to AMR/Arlington Medical Resources, in 2005 there were more than 7 million cardiac studies conducted in the US out of a total of over 15 million nuclear medicine procedures; making MPI the most widely performed nuclear medicine scan. Recent market research indicates that existing MPI products generate revenues in excess of $500 million annually in the US and that the imaging agent most often used in conducting MPI procedures is sestamibi labeled with the radioactive isotope Technetium-99m (Tc-99m Sestamibi).
Once its 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 for the United States. Draximage also plans to file for marketing approvals in other jurisdictions, including European countries.
Cardiac imaging with Tc-99m Sestamibi
The sestamibi kit is used in nuclear medicine imaging to show how well the heart muscle (myocardium) is supplied with blood (perfused) 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).
