FDA Finds Vytorin

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According to the US Food and Drugs Administration (US-FDA) reviewers, Merck’s cholesterol lowering drug called Vytorin is effective lowering the rate of heart attack or other cardiovascular problems among patients with kidney disease.

Merck’s blockbuster drug, according to the FDA review panel, is a mix of Zetia, a new type of cholesterol fighting drug and an older statin drug Zocor, is least likely to cause or promote cancer among patients.

“Risk of cancer did not increase consistently over time with longer use of ezetimibe/simvastatin, as would be expected if a drug caused cancer or promoted the growth of pre-existing cancers,” shares FDA researchers in their documents, ahead of an advisory panel that will look at Zetia and Vytorin on November 2.

The review of FDA as regards the drug will help bring down fears about the popular drug since the 2008 clinical trial showed a potential for developing cancer among patients taking the drug, against those taking placebos.

“In our opinion, FDA’s review of SHARP strongly supports Zetia’s safety,” Leerink Swann analyst Seamus Fernandez wrote in a note.

“Most importantly, the FDA reviewer comments and safety review suggest no new safety concerns and that Vytorin/Zetia is not associated with risk of either incident cancer or cancer deaths. We believe these data should help lay to rest investor concerns about Vytorin/Zetia’s safety.”

Vytorin and Zetia, both with the generic ezetimibe, are approved for lowering cholesterol levels. Merck is also looking forward to expanding the indications of the drug, i.e. treating heart problems among patients with kidney disease, making it the first drug to have that specific indication.

According to the World Kidney Day Organization, “the frequency of CKD continues to increase worldwide as does the prevalence of end-stage renal disease (ESRD). The most common, but not only, causes of CKD are hypertension and diabetes. The presence of CKD is associated with a large increase in cardiovascular (CV) risk. Moreover, CV risk increases proportionally as eGFR falls below 60 ml/min. Lastly, death from CV causes is eight-fold higher in CKD, much higher than death from cancer. Consequently, the identification and reduction of CKD has become a vital public health priority.”

Furthermore, “the most recent report of the United States Renal Data System estimates that nearly one-half million patients in the United States were treated for ESRD in the year 2004, and by 2010 this figure is expected to increase by approximately 40%. The elderly are a growing segment of the population and at increased risk for renal disease. Additionally, males and African-Americans with pre-existing hypertension or diabetes and CKD are also at much higher risk for ESRD. These observations have also been confirmed throughout the developed world: Europe, Asia, Australia as well as in developing regions such as China, India and Africa.”

The patents for both Vytorin and Zetia both expire in 2017, which means Merck is left with barely six years to gain profit from any combination therapy of the drug before the chemical composition of the drug becomes public domain.

Because of the concerns regarding its safety and long term use, Vytorin and Zetia have suffered from sale blows left and right. Nonetheless, Vytorin posted sales of $2 billion and Zetia with $2.3 billion last 2010.




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