Amgen Gets FDA ‘Fast-Track’ Status

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Amgen Inc. announced on Wednesday that the Food and Drug Administration has granted priority review to ivabradine, an oral drug for the treatment of chronic heart failure.

The Thousand Oaks biopharmaceutical company has completed Phase III human clinical studies on ivabradine, and in April the drug qualified for “fast-track” status by the FDA, allowing the company to submit its new drug application in parts, known as a “rolling review.”

Priority review is given to applications for new drugs that treat serious conditions and would, if approved, provide significant improvements in safety or effectiveness. For a priority review, the FDA has a goal of making a decision within six months, compared to a year for a regular application.

Shares closed up 56 cents, or less than 1 percent, to $137.83 on the Nasdaq.

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