FDA knocks Sanofi's Multaq down a peg

The once-brilliant prospects in Sanofi's ($SNY) Multaq have dimmed further. U.S. regulators, as expected, have taken action to keep patients with permanent atrial fibrillation from taking the French pharma giant's heart drug after a review of data that showed an increase in cardiovascular risks to such patients who took the med.

A review found that the drug "doubles the rate of cardiovascular death, stroke, and heart failure" in patients with permanent AF, a form of irregular heart rhythm, according to the FDA. Its update to Multaq's label, which follows an earlier update warning that the drug can cause liver complications, comes after French regulators decided to no longer pay for the drug and the European Medicines Agency restricted its use to patients for whom previous treatments had failed. Sanofi, which is now marketing the drug to treat non-permanent AF, has conceded the permanent AF indication for the drug after a series of setbacks due to safety issues.

"We're fully committed to patient safety and updating our labels whenever the information comes in that would be useful," said Dr. Paul Chew, U.S. chief medical officer at Sanofi, as quoted by Reuters. "We fully agree with the FDA that patients with permanent AF should not use the product."

The FDA's action on Multaq could have been worse for Sanofi. Sanford Bernstein analyst Tim Anderson noted that that there was some fear that U.S. regulators would pull the heart drug from the market completely, according to the Associated Press.

No longer a blockbuster hopeful, Multaq had global sales of $179 million in the first half of this year, The Wall Street Journal reported. The U.S. is apparently the largest national market for the drug, which the FDA says was prescribed to 278,000 patients in the U.S. from the date of its approval in July 2009 to October 2011. The drug, which is now in 39 markets, has been prescribed to more than half a million patients, says the WSJ.

- here's the FDA statement
- read the WSJ article
- see the AP's coverage
- and Reuters' report