The US FDA has approved new uses for Bayer’s and Johnson & Johnson’s anticoagulant Xarelto that could expand the market for the drug by up to $1bn.
The agency gave the nod for Xarelto (rivaroxaban) to be used in the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), as well as to reduce the risk of recurrent DVT and PE following initial treatment.
The oral Factor Xa inhibitor is already FDA-approved to reduce the risk of DVT and PE after knee or hip replacement surgery and to reduce the risk of stroke in people with non-valvular atrial fibrillation (AF), and J&J said the new indication gives Xarelto the “broadest indication profile of any of the newer oral anticoagulants”.
“Xarelto is the first oral anticlotting 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 Haematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research (CDER).
The approval goes some way towards alleviating Bayer and J&J’s disappointment back in June when Xarelto was turned down by the FDA as a treatment for patients with acute coronary syndrome (ACS), with the agency asking for more data.
The latest approval for Xarelto was granted on the back of three clinical trials which found the drug was as effective in DVT and PE as a combination of Sanofi’s Lovenox (warfarin) and a vitamin K antagonist (VKA), and significantly more effective than placebo.
Around 2.1 per cent of patients treated with Xarelto experienced a recurrent DVT or PE in the studies, compared with 1.8-3 per cent of patients treated with the enoxaparin/VKA combination.
DVT and PE affect an estimated 300,000 to 1,600,000 patients each year in the US, killing between 60,000 and 100,000 people, and represent a sizeable new market for Xarelto.
Bayer recorded Xarelto sales of €191m in the first nine months of 2012, up from €55m in the same period of 2011, and has said it expects the drug to achieve upwards of €2bn at peak.