RPT-UPDATE 2-Sanofi wins FDA approval for Multaq heart drug
(Repeats to correct USN)
* U.S. FDA clears Multaq for atrial fibrillation, flutter
* Sanofi says plans commercial launch this summer
* Multaq not for patients with severe heart failure
* Sanofi shares up as much as 1.7 pct, outperform peers
(Adds detail, background, shares)
By Caroline Jacobs
PARIS, July 2 (Reuters) - Sanofi-Aventis (SASY.PA) won approval to sell heart treatment Multaq in the United States, a move that should help the French drugmaker partly recoup a future sales drop as generics to several key drugs appear.
Analysts see Multaq, put forward as a blockbuster, as one of the growth drivers Sanofi has up its sleeve to drag it through the years when patents expire on multi-billion euro drugs like cancer treatment Taxotere and blood thinner Plavix.
The Food and Drug Administration cleared (FDA) Multaq twice-daily 400 mg tablets to reduce the risk of cardiovascular hospitalisation in patients with atrial fibrillation or atrial flutter, Sanofi said on Thursday. Doctors may not prescribe Multaq to patients with severe heart failure.
"This is an expected positive, which breaks Sanofi's eight-year streak of not getting an important non-vaccines drug onto the market," UBS analyst Gbola Amusa said, forecasting sales of as much as 1.4 billion euros by 2014, 2015.
Sanofi said it would begin marketing Multaq, generically known as dronedarone, in the United States this summer.
Diabetes drug Lantus was Sanofi's last main launch in 2001. Since then it has turned into a top drug -- making 2.45 billion euros in sales in 2008 -- but its image was blemished last week following inconclusive studies that suggested a possible cancer risk. [ID:nLQ702256] [ID:nLT701339]
Sanofi stood by Lantus, saying it was safe, while European and U.S. healthcare regulators doubted a link between Lantus and cancer, saying patients should not stop using the drug. [ID:nN01499526]
The approval of Multaq, which awaits clearance by the European regulator, helped push up Sanofi's recently battered shares. They added 0.5 percent to 43.36 euros by 0834 GMT, beating a 0.8 percent drop in the DJ healthcare index .SXDP.
