Bayer and Johnson & Johnson have received good news from regulators in the USA who have agreed to speed up reviews of their oral anticoagulant Xarelto for the treatment of deep vein thrombosis and pulmonary embolism.
The US Food and Drug Administration has granted priority preview to the supplemental New Drug Applications filed two months ago for Xarelto (rivaroxaban) to treat patients with DVT or PE and to prevent recurrence of the two conditions. The review, given to drugs that offer major advances in care or provide a treatment where no adequate therapy exists, will see the agency evaluate the drug in six months rather than the usual ten-month timeframe.
The FDA will evaluate data from the EINSTEIN programme involving almost 10,000 patients in three Phase III trials which showed that Xarelto was as safe and effective as the current dual therapy approach of subcutaneous enoxaparin (Sanofi's Lovenox) followed by warfarin in treating patients with PE or preventing a secondary VTE. Bayer Healthcare head of development, Kemal Malik, said the EINSTEIN studies "have demonstrated convincingly that rivaroxaban can offer physicians a simple, single-drug solution for both the initial treatment of DVT or PE as well as the long-term prevention of recurrent VTE".
Xarelto stent thrombosis submission pulled
However, Bayer also announced it has withdrawn a filing with the FDA for Xarelto to reduce the risk of stent thrombosis in patients with acute coronary syndrome.
The decision has been prompted by the complete response letter the Leverkusen-based firm received last month from the FDA regarding a separate sNDA for Xarelto to reduce the risk of secondary cardiovascular events in patients with ACS. Dr Malik said the firm and J&J "are putting all our efforts behind" addressing the questions raised by the FDA in the CRL as soon as possible and will resubmit the sNDA for stent thrombosis at the same time as it replies to the agency.
Xarelto was first approved in the USA in July 2011 for VTE prevention in adults following elective hip or knee replacement surgery and last November the FDA gave the Factor Xa inhibitor the green light to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.