J&J and Bayer's drug Xarelto fails to impress FDA

The market for the drugs related to heart complications is very vast resulting in a huge rise in the financial growth of the company. The approval of Xarelto for acute coronary syndrome cure by FDA may have resulted in a strong competition.

Sydney, Australia (prHWY.com) June 28, 2012 - The FDA (Food and Drug Administration) in its recent response has turned down the approval request made by the drug companies J&J and Bayer for expanded use of its medication Xarelto for prevention of strokes and heart attacks in individuals suffering from acute coronary syndrome.
The approval of the drug by the FDA against the common heart ailment may have drastically increased the market value of the drug along with enhancing the financial status of its manufacturing companies.
Acute coronary syndrome is reported to be afflicting more than millions of individuals with around 1.2 million hospitalizations seen on a yearly basis. The FDA has approved Xarelto way back in 2011, for preventing clots in patients undergoing hip and knee surgeries and also for prevention of strokes in atrial fibrillation patients.

But, the missing clinical data of around 1,300 patients, who dropped out of the study midway and also withdrew the permission to access their health information, has created a big hurdle in the approval of the drug for use in the larger group of heart patients, as the interpretation of the data related to its clinical trial was left incomplete.
Hence, the absent data of 1300 individuals of the overall 15,526 participants has led to disapproval of the use of Xarelto for prevention of heart complication and stroke in individuals experiencing severe chest pain or with a history of heart attack.
Paul Burton, a member of Research & Development unit of the company claimed that they will resume their talk with the FDA as early as possible and will accurately address their queries in an efficient manner.
This approach proves that Johnson & Johnson are very confident of the drug's advantages and hence, its approval for use in the treatment of patients suffering from acute coronary syndrome.
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Tag Words: health, heart patients

Categories: Health

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