France is turning its back on Multaq. Health officials say the French government will no longer pay for the Sanofi ($SNY) heart rhythm drug after a series of studies raised questions about Multaq's safety. It's just the latest blow to the drug's prospects; once pegged as a blockbuster, Multaq has suffered one setback after another since its approval.
The move isn't a huge surprise. France's Haute Autorite de Sante recommended back in July that Multaq be withdrawn from the state formulary. But it's more extreme than other regulatory decisions about the drug: For instance, in September, the European Medicines Agency limited Multaq's use to patients who'd failed on alternative treatments, but maintained that the drug can be useful for some patients with the non-permanent forms of atrial fibrillation.
Sanofi disagrees with France's choice, Reuters reports. It's the only European country to stop paying for Multaq, the French drugmaker said. Plus, said CMO Jean-Pierre Lehner, the decision is "not based on medical evidence and harms the appropriate patients who are currently treated with Multaq."
FDA, meanwhile, is still reviewing Multaq safety. The agency started looking into reports of liver failure in a few Multaq patients, then broadened that investigation after Sanofi stopped the PALLAS trial, which tested Multaq in patients with permanent AF. The agency has suggested that Multaq patients talk to their doctors, recommended against its use in permanent AF patients, and added warnings and other information to the drug's label, but hasn't moved to restrict its use. The agency says it's now looking at Multaq safety in the temporary AF patient population.
Full data from the PALLAS study was reported at the American Heart Association meeting earlier this week, and it concluded that patients with permanent AF shouldn't use Multaq. Patients taking the drug were about twice as likely to die from cardiovascular causes as those in the control group, and they experienced higher rates of stroke and hospitalization for heart failure.
- here's the Reuters piece