File this under tough sell. The drug more than doubled the risk of death in people with heart failure in a study that was terminated early in 2003 due to safety concerns,Dow Jones reports.
Sanofi still plans to resubmit the drug, dronedarone, for regulatory approval this fall, because a more recent study suggested the drug reduced the risk of death in patients with atrial fibrillation. Two years ago, the FDA rejected the drug, called Multaq. "I would say a majority of patients would be eligible for this treatment," Paul Chew of Sanofi's R&D unit tells Dow Jones.
Meanwhile, the newly published data suggests Multaq shouldn't be used by people with severe heart failure because it appears to worsen heart failure, the wire notes. Hmm... That might dampen use of a drug that Sanofi hopes will generate annual sales of more than $1 billion.
The study in The New England Journal of Medicine shows that 25 of about 310 people who took Multaq died after two months, versus 12 deaths among 317 people given a placebo. The death rates in the Multaq group were 8.1 percent compared with 3.8 percent in the placebo group.
Among those who died during the study, 10 Multaq users had worsening heart failure, compared with two in the placebo group, which suggests Multaq contributes to worsening heart failure, according to the researchers.