Anticoagulant Xarelto (rivaroxaban) has been recommended by the FDA’s Cardiovascular Renal Drugs Advisory Committee for the prevention of systemic embolism and stroke in patients with non-valvular AF (atrial fibrillation). The Committee, also known as the Panel, voted 9 to 2 in favour, with 1 abstention.
The FDA (Food and Drug Administration) is expected to make a final decision on September 8th. The Panel’s verdict is not binding; the FDA can ignore the recommendation if it so wishes. However, this rarely happens.
Bayer Healthcare holds the rights to sell rivaroxaban outside the USA, while Janssen Pharmaceuticals Inc. has the rights to market it inside the USA. Janssen is a Johnson & Johnson company.
Janssen had submitted an NDA (New Drug Application) for rivaroxaban in the USA on January 5th this year for the prevention of stroke and systemic embolism in individuals with non-valvular AF.
Bayer has submitted rivaroxaban for market authorization for the same indication as well as DVT treatment and the prevention of recurrent DVT and PE to the European Medicines Agency (EMA). A submission has also been presented to Japanese authorities.
Xarelto was approved recently for blood clot prevention after some orthopedic surgical procedures. Having approval for stroke will give Janssen access to a much greater number of patients.
Warfarin has been used for stroke prevention for over 50 years. With Warfarin, doctors need to regularly measure its levels in the bloodstream, which is not the case with Xarelto. However, Warfarin is far cheaper.
According to Bayer and Janssen, Xarelto is more convenient for patients, and has fewer side effects.
The heart has two upper chambers – the atria – and two lower chambers – the ventricles. The atria consist of a right and left atrium, and the ventricles are called the left and right ventricle. When the atria contract too rapidly and/or irregularly, the patient has atrial fibrillation. Atrial fibrillation is the most common type of arrhythmia, which is caused when there is a disorder in the heart’s electrical system. Arrhythmia is a problem with the speed or rhythm of the heartbeat.
AT affects over 6 million Europeans, more than 2.3 million Americans, and approximately 800,000 patients in Japan.
AT patients are vulnerable to the formation of blood clots in the atria. The clot can make its way through the bloodstream to the brain, where it can cause a stroke. Strokes can lead to brain damage, which in turn can result in serious physical and behavioral problems, and even death.
An individual with AT is five times more likely to have a stroke compared to the general population. In fact, about one-third of AT patients do suffer a stroke.
Written by Christian Nordqvist