CVD drug approval watch
Two pharma companies, Abbott Laboratories and AstraZeneca PLC have joined forces to apply for the approval of a combo-pill containing two cholesterol drugs TriLipix and Crestor to the US Food and Drug Administration (US FDA). Abbott is the maker of TriLipix which belong to a class of drugs called fibrates that raise the levels of “good” HDL cholesterol and lower the levels of triglycerides. Crestor, manufactured by AstraZeneca is a statin that lowers “bad” LDL cholesterol and raises HDL.
The combi drug would be a strong therapyA against dyslipidemia, a disorder characterized by elevated bad cholesterol and triglycerides, and low good cholesterol levels. If approved, the drug would be called Certriad
Crestor was London-based AstraZeneca’s third best-selling product last year with sales of $3.6 billion. Trilipix was launched last December. The drug had sales of $253 million in the first quarter, when combined with a related treatment called Tricor.
CVD drug and medical safety watch
- Recalls of Digoxin and Propafenone Tablets
These two cardiac drugs were recalled because the tablet sizes were variable and may therefore not contain the amount of active ingredients declared in the labels. The digoxin was recalled by Caraco Pharmaceutical Laboratories. Propafenone was recalled by Watson Pharmaceuticals.
- Recall of Medtronic Ventricular Snap Shunt Catheters
Medtronics recalled Bioglide Ventricular Snap Shunt Catheter due to danger of detachment from the base shunt system.
- Recall of Zencore Plus
Zencore Plus, a nutritional supplement product, has been recalled by Bodee LLC is after aUS FDA labanalysis showed that it contains benzamidenafil. A person taking organic nitrates who also took Zencore Plus could experience a sudden and profound drop in blood pressure, which would pose a significant health risk.
CVD clinical trial watch
Avandia on the RECORD: No “overall” CV risk increase, but trial remains controversial
The story about Avandia (rosiglitazone) is not yet over. The diabetes drug does not increase cardiovascular risk, according to the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial. However, sceptics remain sceptical and the drug remains controversial. Avandia is a product of GlaxoSmithKline. “Although our evidence is insufficient to rule out a small increased risk of myocardial infarction caused by rosiglitazone when compared with other glucose-lowering agents, rosiglitazone does not increase overall cardiovascular morbidity or mortality.”