Added indication for Bayer's Xarelto in Japan

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved German pharma major Bayer’s (BAYN: DE) Xarelto (rivaroxaban) for an additional indication, the treatment and secondary prevention of pulmonary thromboembolism and deep vein thrombosis.

Xarelto is already a significant earner for Bayer, generating second-quarter 2015 sales of 549 million euros ($615 million) ,a rise of 42.6% year-on-year. Though not necessarily linked to the Japan approval, shares of Bayer gained 3.6% to 117.20 euros by early afternoon trading today.

“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 Joerg Moeller, a 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,” Dr Moeller added.

This MHLW approval of Xarelto is based on data from the global EINSTEIN Clinical Trial Program, and is supported by the J-EINSTEIN studies (J-EINSTEIN DVT and J-EINSTEIN PE), which were run entirely in Japan. The EINSTEIN Clinical Trial Program demonstrated the efficacy and safety profile of rivaroxaban in the treatment of patients with acute symptomatic PE or DVT and the prevention of recurrent PE and DVT in these patients, the company noted.