Daiichi Sankyo Inc and Eli Lilly received approval from the US Food and Drug Administration (FDA) for Effient (prasugrel) tablets to be used for the reduction of thrombotic cardiovascular events. Effient reduces thrombotic cardiovascular events (including stent thrombosis) in patients suffering from acutecoronary syndromes and undergoing an artery-opening procedure known as percutaneous coronary intervention (PCI). PCI usually includes the placement of a stent to help keep the artery open.

The FDA has approved tadalafil, the active ingredient in the erectile dysfunction drug Cialis, to improve exercise ability in people with pulmonary arterial hypertension, which is a rare, life-threatening lung disorder. This disorder causes high blood pressure in lungs. Tadalafil, manufactured by the drug company Lilly, will be available in the U.S. as Adcirca in August by United Therapeutics Corporation.

Researchers have indicated that an enzyme found in coronary plaques may be responsible for significant number of cardiac patients suffering from heart attacks and stroke, despite the widespread use of cholesterol-lowering drugs. The enzyme makes plaque more vulnerable to rupture and block blood flow. According to new research, the drug darapladib, taken in adjunct to the treatment of statin drugs, may offer a way to fight that risk as it safely and effectively lowers the activity of the Lp-PLA2 enzyme.

Photo by Patrick J. Lynch

The FDA has decided to continue to regulate Vasogen’s Celacade system as a medical device. The Celacade system is a treatment for patients with New York Heart Association (NYHA) Class II heart failure. The FDA’s Center for Biologics Evaluation and Research (CBER) is to take over as the lead reviewer of the programme. The CBER has informed Vasogen that it does not agree with the use of a Bayesian approach in the ACCLAIM II study of the system. The FDA had earlier recommended the design.