FDA panel backs Sanofi's megablockbuster Multaq

An expert panel at the FDA voted 10 to 3 in favor of recommending approval of Sanofi-Aventis' new heart drug Multaq. But investors seemed largely unmoved by the endorsement of the drug--widely seen as Sanofi's most important near-term prospect--at least in part because of some recommended restrictions that will dull its earning power.

Analysts now expect Multaq to hit the market in the second half of this year following a likely approval by the agency in coming weeks. But the panel is recommending that the drug should not be given to patients with severe heart failure and added that Sanofi should not be allowed to claim that the therapy reduces the risk of death. Combine those two qualifications, says Morgan Stanley, and the agency could reduce Multaq's earning potential by as much as 10 percent.

Morgan Stanley, though, says that Multaq has the potential to earn €3 billion a year by 2015, more than double most estimates. Citigroup pegs sales potential at $1.3 billion to $1.9 billion. Sanofi's share price, however, barely budged on the news.

Sanofi had to battle long and hard to reach this stage. In 2006 the FDA rejected the drug [1] when data linked it to a higher death rate. But a new study showed a significant reduction in the rate of hospitalizations due to atrial fibrillation.

- check out the AP report [2]

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Potential Sanofi blockbuster gets FDA staff endorsement [3]
Sanofi-Aventis scores positive data in Multaq trial [4]
Sanofi-Aventis wins priority review for Multaq [5]