With an expert panel review looming on Wednesday, the leader of the FDA's drug review team says that Sanofi-Aventis' Multaq--a prospective blockbuster--should be approved for treating a common heart rhythm problem.
Multaq "should be approved for the delay and recurrence of symptomatic events and decrease hospitalization for atrial fibrillation," says the memo on Multaq. But the team leader also advised against approving the drug with claims that it lowers the risk of death.
Analysts have pegged Multaq as a mega-blockbuster likely to earn more than $2 billion in annual sales revenue. Positive trial data has demonstrated that the therapy reduced the risk of cardiovascular hospitalization or death by 24 percent in patients with atrial fibrillation or heart flutter. Analysts have also predicted that the agency will ultimately OK the drug for marketing.
- check out the report on Multaq from Dow Jones