European Medicines Agency restricts use of Sanofi’s Multaq
European regulators have decided to restrict use of Sanofi’s anti-arrhythmic Multaq.
In July, the French drugmaker discontinued the PALLAS trial in patients with permanent atrial fibrillation, different from the population with non-permanent AF for which Multaq (dronedarone) is currently approved. A significant increase in cardiovascular events was seen in the dronedarone arm, so the study was pulled. The European Medicines Agency (EMA) then began a safety review and their Committee for Medicinal Products for Human Use (CHMP) has now recommended restricting use.
Specifically, the Committee for Medicinal Products for Human Use said Multaq should only be prescribed for maintaining heart rhythm in patients with paroxysmal or persistent AF for the maintenance of sinus rhythm after successful cardioversion. It also says that due to an increased risk of liver, lung and cardiovascular adverse events, Multaq should only be given after alternative treatment options have been considered and recommended a number of other risk minimisation measures.
However, the committee also noted that “the availability of a range of treatments for a difficult condition such as AF was important” and that for some patients with non-permanent AF, “Multaq remains a useful treatment option”. As such, the committee argues that “the benefits of Multaq outweigh its risks in these patients”.
It was this latter position that Sanofi stressed. Jean-Pierre Lehner, chief medical officer for Sanofi, said the committee’s opinion is significant “as it ensures availability of an important treatment option for paroxysmal and persistent atrial fibrillation, a growing public health concern associated with life threatening consequences”.
Multaq has been launched in 37 countries and has been prescribed to over 440,000 patients to date. It was originally touted as a blockbuster but analysts believe that the EMA restrictions (and the fact that the US Food and Drug Administration is also reviewing the drug) means that it should no longer be seen as a flagship product.