Bayer and partner Johnson & Johnson have been given another thumbs-up for their bloodthinner Xarelto by regulators in the USA.
This time, the US Food and Drug Administration has approved Xarelto (rivaroxaban) both to treat and to reduce the risk of recurrence of deep vein thrombosis and pulmonary embolism. The agency approved the drug for the new indications on a priority review timeline of six months instead of 10 months.
This makes it "the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin nearly 60 years ago,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
The approval for these new uses was based on data from the EINSTEIN programme which included three Phase III studies involving almost 9,500 patients. Before, "a patient who presented with a DVT or a PE would face a treatment that involved multiple medications," said Kemal Malik, head of global development at Bayer HealthCare, adding that Xarelto offers physicians "an effective, well-tolerated and convenient single-drug solution".
Xarelto was first approved in the USA in July 2011 for the prevention of venous thromboembolism in adults following elective hip or knee replacement surgery. The Factor Xa inhibitor got another green light in November of last year to reduce the risk of stroke in people with non-valvular atrial fibrillation but in June this year, the FDA declined to approve Xarelto to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome and requested further information; Bayer and J&J submitted their response in September.
Other drugs approved by the FDA to treat or reduce the risk of blood clots include Sanofi's now off-patent Lovenox (enoxaparin), GlaxoSmithKline's Arixtra (fondaparinux) and Pfizer's Fragmin (dalteparin), plus warfarin and heparin.
Russian pact for Bayer
Staying with Bayer, the German group announced it has linked up with Russia's Medsintez to jointly manufacture and commercialise diagnostic imaging products as well as pharmaceuticals to treat infections and neural disorders.
The companies say they also intend to cooperate in the R&D and production of new substances and medicines, "aiming to accelerate the access to innovative pharmaceuticals for Russian patients". First up, they will manufacture Bayer's anti-infectives Avelox (moxifloxacin) and Ciprobay (ciprofloxacin), the neural disorder treatment Nimotop (nimodipine) and diagnostic imaging products "in existing as well as new facilities which will be built according to latest Good Manufacturing Practice requirements".