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Dec 17, 2007
 |  BioCentury  |  Regulation

Pulzium: A matter of risk

Regulation

Pulzium: A matter of risk

FDA's Cardiovascular and Renal drugs advisory committee unanimously voted to recommend against approval of Pulzium tedisamil from Solvay S.A. to convert patients from atrial fibrillation to sinus rhythm based in part on what is known about the product, and even more on what isn't known.

The committee was worried by arrhythmias that occurred in patients who received Pulzium, and felt that results from Solvay's trials can't be generalized to the patients who would be exposed to the compound in the U.S.

In addition, the committee expressed concerns that the complex dosing and administration procedures could lead to accidental overdoses.

The committee discussed Pulzium on Wednesday, a day after it decided that pharmacological conversion of AF to sinus rhythm (cardioversion) provides a meaningful benefit to patients(see Cover Story).

As with Kynapid vernakalant from Cardiome Pharma Corp. (TSX:COM; CRME, Vancouver, B.C.) and Astellas Pharma Inc. (Tokyo:4503, Tokyo, Japan), the committee found Pulzium's efficacy data convincing.

The primary endpoint for the Pulzium trials was the percentage of patients who converted to normal sinus rhythm for at least one minute at any time within 2.5 hours after the initiation...

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