Stall Entry of Serelaxin in US, Suggests FDA

The US Food and Drug Administration (FDA) has said that heart-failure drug Serelaxin, manufactured by Swiss drug maker Novartis, should not be allowed to enter the US market.

The FDA advisory panel came up with the suggestion and said the drug failed to show any improvement in the condition. Serelaxin helps in dilating blood vessels and removing pressure from the heart.

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The panel was critical about the data and said the trial successfully met only one of its two primary endpoints.

In late January, even European regulators did not approve marketing of the drug. In about 16 countries across the globe, the drug is being assessed by health authorities for the treatment of acute heart failure.

The suggestion by the FDA review panel does not necessarily mean the drug will not be sold in the US, though it does have its importance. The FDA's Cardiovascular and Renal Drugs Advisory Committee will discuss and vote on the biologics license application or BLA for Serelaxin injection.

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In heart failure, the heart cannot pump enough blood around the body. Over 15 million people suffer from heart failure globally and the figure is constantly increasing.

Source-Medindia

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