The European Medicines Agency (EMA) which – as I said yesterday – is the European FDA, is broadening its review of Multaq, the atrial fibrillation treatment, after a study found potential cardiovascular risks in some patients. This is serious, I think it is fair to say. If you are taking Multaq, you don’t exactly need a heart problem.
Sanofi Aventis announced the discontinuation of a Multaq study on the advice of its safety board. The discontinuation of the tests was claimed to be due to “events” suffered by patients within the study after being prescribed Multaq. The same events were not noticed among those patients who were administered a placebo.
There were over three thousand patients participating in the study, each of whom was over sixty-five years of age. Each was instructed to discontinue their Multaq regiment for purposes of a permanent atrial fibrillation. The drug has been previously okayed for temporary usage for the same condition. The EMA will be looking at the results of this study. Give Sanofi some credit: when they saw the iceberg, they did not hit the gas pedal and keep the study going hoping the data would get better.
In January, the FDA considered the possibility of a potential risk of Multaq to the liver, noting that two patients, who had been administered Multaq, suffered acute liver failure and ultimately required liver transplants. Two weeks following the warning, the FDA admonished – there should be a stronger word – Sanofi Aventis for their failure to note adverse event reports which expressed concerns of Multaq.
There have been nearly five-hundred thousand prescriptions for Multaq (dronedarone) since its approval for patent and use in 2009 for over one-hundred and forty thousand individuals. Multaq is also administered to those being treated in a hospital. The drug is most used for abnormal heart rhythms and palpitations that have occurred within six months.
The investigation into the drug has impacted Multaq’s market share. Sanofi is feeling the pain in their stock price as well. (It didn’t help that their multiple sclerosis drug candidate Lemtrada didn’t meet its goals in a clinical trial, either.)
It will be interesting to see what Europe does with Multaq. Are Multaq lawsuits on the horizon? We are not investigating potential Multaq lawsuits right now. Could that change? Yes.