The FDA’s Cardiovascular and Renal Drugs Advisory Committee and Circulatory System Devices Panel are each set to meet next week, when they will evaluate the drugs rivaroxaban and dronedarone and the TherOx Aqueous Oxygen System for infarct size reduction.
On Wednesday, March 18 the cardiorenal committee will discuss Sanofi’s new drug application for dronedarone in patients with a history of, or current atrial fibrillation or atrial flutter, for the reduction of the risk of cardiovascular hospitalization or death. Here’s the FDA web page for the meeting.
On Thursday, March 19, the cardiorenal committee will discuss Johnson & Johnson’s rivaroxaban oral tablets (10 milligrams) for the proposed indication for use in prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip replacement surgery or knee replacement surgery. Here’s the FDA web page for the meeting.
On Wednesday, March 18 the circulatory panel will discuss the premarket approval application, sponsored by TherOx, Inc., for the TherOx Aqueous Oxygen System (AO System). Here’s the FDA web page for the meeting. This is how the FDA describes the AO System:
The system is intended for use in acute myocardial infarction (AMI) patients, who have undergone successful revascularization less than or equal to 6 hours from symptom onset. These patients are then randomized to AO Therapy or not. The endpoint is reduction in the final size of the infarct. The system draws blood from the patient, hyperoxygenates it with the AO cartridge component of the system, and reinfuses the blood via the infusion catheter directly to the infarction site of the heart. This therapy is intended to be performed for 90 minutes post percutaneous coronary intervention/stenting.
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