European Committee Gives Positive Opinion for Multaq in Treating AF
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Last week the Committee for
Medicinal Products for Human Use (CHMP) a part of the European Medicines Agency
(EME) gave their positive opinion for Multaq to be marketed in the European Union.
The medication known as dronedarone, would be available in 400mg tablets.
Last week the Committee for Medicinal Products for Human Use (CHMP) a part of the European Medicines Agency (EME) gave their positive opinion for Multaq to be marketed in the European Union. The medication known as dronedarone, would be available in 400mg tablets.
The manufacturer of Multaq, Sanofi-aventis is happy about the positive opinion and is looking forward to it being ratified by the European Commission. Its goal is to provide an effective treatment for people who suffer from atrial fibrillation and prevent further complications from the condition.
Multaq is a drug that would be used in treating adults who currently have atrial fibrillation (AF) or who have a history of the condition. The medication would be used to lower the ventricular rate as well as prevent future occurrences of atrial fibrillation. Multaq has been shown to reduce the number of hospitalizations as a result of these results.
One of the most common forms of arrhythmia, atrial fibrillation occurs as a result of the heart’s electrical system. The heart rate is affected when the electrical signals in the upper two chambers of the heart begin to contract irregularly and rapidly. When this happens the blood settles in the atria and doesn’t get pumped into the heart’s two lower chambers completely. This puts the upper and lower chambers out of sync with each other.
You could have had a bout with atrial fibrillation and not even realized it if your heart didn’t beat that fast or if it didn’t last that long. On the other hand, if it is severe atrial fibrillation can cause a heart attack, chest pains or even heart failure. If it is not taken care of it could put you at a greater risk of having a stroke. In some people it is a chronic situation but in others it can actually happen every now and then and even go away.
The CHMP based its opinion on a comprehensive package of information regarding Multaq that was derived from seven randomized international clinical trials that were held at several locations utilizing data from over 7,000 patients. It also took into account information based on the ATHENA trial.
The ATHENA trial was a clinical test that produced results using 4,628 people who had atrial fibrillation. The results of this trial showed that Multaq, which was used along with standard treatment, reduced the number of hospitalizations as well as deaths by 24 percent when compared to the effects of a placebo. The most significant side effects that resulted from the trial were nausea, diarrhea, bradycardia cutaneous rash and QT-interval prolongation.
Cases of atrial fibrillation are growing around the world, and with around 4.5 million people affected one third of those hospitalized are in the European Union. Multaq has already received approval from the Food and Drug Administration in the United States as well as Health Canada and Swissmedic, the Swiss Health Authority.