UK NICE says final "yes" for Bayer's Xarelto to treat blood clots

Confirming its final draft guidance last month (The Pharma Letter June 1), in final guidance published today (July 25), the UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has recommended German drug major Bayer’s (BAYN: DE) oral anticoagulant Xarelto (rivaroxaban) as an option for treating deep vein thrombosis and preventing recurrent deep vein thrombosis and pulmonary embolism in adults diagnosed with acute deep vein thrombosis (DVT).

Risk factors for VTE include a history of DVT, recent surgery, immobility, active cancer or cancer treatment, age over 60 years, obesity, hormone replacement therapy or oestrogen containing contraceptive therapy and the presence of co-morbidities such as heart disease. It is estimated that there will be over 46,000 cases of acute DVT in England and Wales during 2012, rising to nearly 50,000 by 2016 due in large part to the aging population.

Treatments for VTE include initiation with injectable anticoagulants such as low-molecular-weight heparin or fondaparinux sodium. Treatment is then overlapped with a vitamin-K antagonist, such as warfarin, until effective anticoagulation with the oral agent is achieved.