Bayer: Factor Xa inhibitor Xarelto approved in Japan

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved in Japan Bayer’s oral Factor Xa inhibitor Xarelto (rivaroxaban) for the treatment and secondary prevention of pulmonary thromboembolism and deep vein thrombosis, Bayer HealthCare announced on Thursday. 

Deep vein thrombosis (DVT) is a condition in which blood clots form in one of the large, deep veins, usually in the legs, Bayer explains. Pulmonary embolism (PE) is a condition that most commonly occurs when part or all of a DVT dislodges and travels to the lung, via the heart, where it can partially or completely block a branch of a pulmonary artery. When PE occurs with large clots, multiple clots, or when the patient has pre-existing heart or lung disease, the event may be fatal. On average, every 37 seconds someone in the Western World dies from a venous blood clot, making PE and DVT (known collectively as Venous Thromboembolism, VTE) the third most common cardiovascular condition.

“Xarelto provides fast and effective treatment for patients suffering from PE and DVT. While the overall rates of major bleeding and clinically relevant non-major bleeding as the primary endpoint were comparable, Xarelto nearly halved the risk of major bleeding compared with the conventional dual-drug treatment approach”, said Dr Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

“With the approval of Xarelto for the treatment and secondary prevention of pulmonary thromboembolism and deep vein thrombosis, we can now provide physicians and patients in Japan with the first oral treatment without the need for injections.”

Bayer notes that MHLW’s approval of Xarelto is based on data from the global EINSTEIN Clinical Trial Programme, and is supported by the J-EINSTEIN studies (J-EINSTEIN DVT and J-EINSTEIN PE), which were run entirely in Japan.