Novartis heart drug gets FDA's 'breakthrough' status

ZURICH, June 21 Fri Jun 21, 2013 2:01am EDT

ZURICH, June 21 (Reuters) - Swiss pharmaceuticals company Novartis said on Friday U.S. regulators have given breakthrough therapy status to an investigational treatment for patients with acute heart failure, potentially fast tracking its development and approval.

The U.S. Food and Drug Administration (FDA) created the "breakthrough therapy" designation earlier this year for medicines deemed likely to demonstrate "substantial improvement" over existing drugs.

Novartis said the FDA's decision was supported by efficacy and safety results from a late stage trial of its serelaxin, which also showed serelaxin reduced patient deaths by 37 percent at six months after acute heart failure compared to those who received standard therapy.

Novartis said late last year serelaxin was one of the most promising drugs in its pipeline, while Deutsche bank analysts said it could potentially rake in $2.5 billion in annual sales.

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