September 30, 2024 – A brand new FDAapproved The drug will improve diagnosis coronary heart diseaseessentially the most common style of heart disease, affecting greater than 18 million adults within the United States and the leading explanation for death nationwide.
The drug, called Flurpiridaz, sold under the brand name Flyrcado, is given as an injection before cardiac imaging tests Radio tracera substance that helps doctors see contained in the body during an examination. The approval got here under the agency's priority review process, which is reserved for drugs that treat serious diseases and work significantly higher than existing options.
The current standard for examining blood flow through the guts and assessing suspected coronary artery disease (CHD) is Myocardial perfusion imaging using single photon emission computed tomography. It can also be called a nuclear stress test.
With Flyrcado, the test can now be performed using a PET scan – known to be higher at detecting CAD, but not widely used attributable to the challenges presented by other radiotracers.
“Flyrcado is the most exciting development in the field of nuclear cardiology in recent decades,” said Jamshid Maddahi, MD, the principal investigator for the Flyrcado clinical trials and clinical professor on the UCLA School of Medicine, in an announcement Press release from GE HealthCare, the drug's manufacturer. “I am excited about this new radiotracer and its potential game-changing impact on diagnosing the disease with the highest mortality rate in the world.”
While other radiotracers have to be manufactured on-site where testing takes place, Flyrcado could be manufactured off-site and arrive at testing sites ready to be used. The duration is a minimum of 109 minutes, which can allow for added testing in a single session, with time for retesting if mandatory.
According to GE HealthCare, an estimated 6 million people every year receive imaging tests for suspected coronary artery disease. Coronary artery disease is frequently attributable to an issue called atherosclerosis, which occurs when plaque manufactured from fat and cholesterol builds up within the arteries and blocks blood flow. People with coronary artery disease can have chest pain or shortness of breath, and a whole blockage may cause a heart attack.
Flyrcado's approval relies on the outcomes of two studies showing that the drug helped discover 63% to 89% of patients with CAD. One study suggested that using Flyrcado with PET myocardial perfusion imaging was particularly effective in detecting disease in women and other people with obesity.
At least 2% of study participants who took Flyrcado experienced unintended effects equivalent to shortness of breath, headache, sometimes severe chest pain, fatigue, feeling hot, nausea, stomach pain, dizziness and irregular heartbeat.
According to GE HealthCare, Flyrcado can be available in early 2025.