FDA joins Multaq review, reveals prelim study data

FDA has joined the Multaq review effort. The agency said that it is analyzing data from the recently halted trial of Multaq in patients with permanent atrial fibrillation. Sanofi stopped that 3,000-patient study two weeks ago when "a significant increase in cardiovascular events" cropped up in a data analysis.

The FDA, however, revealed some actual, preliminary numbers from that study, known as PALLAS. According to the agency, 16 patients in the Multaq arm died, compared with 7 in the placebo group. The number of patients who died from cardiovascular causes, or had a heart attack, stroke or embolism, was 32 in the Multaq group, versus 14 with placebo. Thirty-four Multaq patients were hospitalized with heart failure, compared with 15 placebo patients.

European regulators are already reviewing the drug; they say they'll release their results in September. In announcing its review, FDA said that a critical question is whether the "unfavorable results of the PALLAS study" apply not only to patients with permanent atrial fibrillation, but also to patients with temporary versions of fibrillation. Multaq is FDA-approved for use in patients with paroxysmal atrial fibrillation and atrial flutter.

Sanofi says "the benefit-risk profile remains positive" for the approved use, the New York Times reports, but advised doctors never to prescribe it for permanent atrial fibrillation. As for FDA's advisory experts, one who voted for Multaq's approval called the PALLAS data "concerning," while Public Citizen's Sidney Wolfe, who voted against, said the drug was "really too dangerous," the Times reports.

- check out the FDA statement
- read the news from Reuters
- get the NYT piece
- see the MedPage story