French authorities have dealt a setback to Sanofi on its heart drug Multaq. The atrial fibrillation treatment has been deemed "inadequate" by health officials, meaning it could be banished from the state reimbursement formulary. The decision comes after two patients developed liver failure while taking the drug, prompting a safety review by French and European authorities, Libération reports.
Multaq launched in 2009, one of the drugs Sanofi hoped would pick up the slack when lucrative older products began to fall off patent. But the launch got off to a slow start; in France, for instance, regulators took their time deciding to declare the drug fit for reimbursement, and then to set the reimbursement level at 65 percent. Nonetheless, analysts had pegged the drug with potential peak sales of more than $1 billion.
Meanwhile, some studies questioned whether Multaq should be used as a first-line treatment for atrial fibrillation, and to quell doubts, Sanofi announced its own outcomes study of heart attacks and strokes in AF patients. Then the liver-failure cases arose. Sanofi issued a "Dear Doctor" letter in the U.S. to warn physicians and other providers about the liver trouble in Multaq patients; the drugmaker stressed that no causal link had been found.
Now, French health officials have moved against the drug. According to Libération, Health Minister Xavier Bertrand will have the last word on whether to delist Multaq from the French formulary. And as the paper points out, officials in France are on high alert after the dust-up over the withdrawal of the Servier drug Mediator.