EMA recommends restricting use of Sanofi AF drug Multaq, but sees positive benefit-risk in some patients

There was mixed news for French drug major Sanofi (Euronext: SAN) yesterday, when the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended restricting the use of Multaq (dronedarone) due to adverse events, but said the benefit-risk balance of the drug remains positive in a limited population of patients with paroxysmal or persistent atrial fibrillation.

Multaq, which has previously been touted as a $4 billion a year drug, has been under review by the EMA and the US Food and Drug Administration since a study, dubbed PALLAS, was stopped early after the data monitoring committee found a two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure in patients receiving Multaq compared to those given a placebo (The Pharma Letter July 8).

“Because the drug will be restricted there will be a minimal amount of sales,” said Vincent Meunier, an analyst for Exane BNP Paribas, telling the Bloomberg news service that “the drug is pretty much dead.” Multaq had sales of 172 million euros ($231.7 million) last year and 68 million euros in the second quarter of this year. Sanofi’s shares dipped 3.1% to 46.50 euros by close of Paris trading yesterday, but this has to be seen against a backdrop of a near 4.7% slump in European markets to a 26 month low.