Several regulatory approvals were announced in May.
The Food and Drug Administration granted marketing clearance for Simulect (basiliximab) for the prevention of acute rejection episodes in renal transplant recipients. Phase III clinical trials in 729 patients showed that two doses of Simulect used with cyclosporine and corticosteroids proportionately reduced the incidence of rejection by 31% during the six months following kidney transplantation. Acute tolerability and the 12-month adverse event profiles were comparable in patients treated with Simulect and patients taking a placebo. Simulect "allows patients to complete antibody induction therapy before leaving the hospital. This helps to ensure full treatment compliance and a timely hospital discharge," said Michael Hall, MD, of Novartis Pharmaceuticals, the maker of Simulect.
Thoratec Laboratories of Pleasanton, California, has received FDA clearance on its premarket approval supplement for the use of its Ventricular Assist Device System in patients recovering from open-heart surgery; the system is already approved for use as a bridge to a transplant in patients awaiting a donor heart. "Significantly, the FDA clearance makes the VAD System the only cardiac assist device available in the U.S. that can be used for both bridge to transplant and postcardiotomy recovery of the natural heart," said D. Keith Grossman, Thoratec's president and chief executive officer. The approval also will make the system the only product in the U.S. "with the ability to treat both short- and long-term patient populations," Thoratec said.
For Your Information:
Simulect prescribing information
(973) 781-8879Thoratec press release
http://www.thoratec.com/invest/press/pr184.htm
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