Xarelto poised for two new chronic indications
pharmafile | September 26, 2011 | News story | Sales and Marketing | Xarelto
Bayer HealthCare’s oral bloodthinner Xarelto has been recommended for approval in Europe for two new chronic indications.
The Committee for Medicinal Products for Human Use said Xarelto (rivaroxaban) should be given the nod for preventing stroke and systemic embolism with non-valvular atrial fibrillation, plus treating deep vein thrombosis and preventing DVT and pulmonary embolism following an acute DVT.
Bayer called the CHMP recommendation a “significant milestone”, and a decision is expected in the final quarter of this year.
The drug is part of a new generation of anticoagulants – along with Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) and Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) – keen to displace the 65-year old injectable warfarin.
If the CHMP decision is ratified by the European Commission Xarelto would be the first of the trio to be given those two new indications plus its existing one: prevention of VTE in patients receiving a new hip or knee.
Bayer is certainly confident. “We expect that we will soon be able to provide patients and physicians in Europe with an effective alternative for the prevention of strokes in patients with AF as well as a new, convenient single drug approach to the treatment of DVT,” said the company’s chief medical officer, Kemal Malik.
Data scrutinised by the CHMP included Xarelto’s results from the phase III ROCKET AF (Rivaroxaban Once-daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for the prevention of stroke and EmbolismTrial in Atrial Fibrillation) trial.
This showed once-daily Xarelto had a 21% relative risk reduction in stroke and non-CNS systemic embolism while on-treatment compared to warfarin, with low and comparable bleeding rates.
Things are going well for the brand: earlier this month, FDA advisors recommended Xarelto be approved in the US for the prevention of stroke and systemic embolism in patients with non-valvular AF.
It was first licensed in July in the US, where Johnson & Johnson’s Janssen Pharmaceuticals holds the marketing rights, for the prevention of deep vein thrombosis – although rival Pradaxa was also approved in the US last year for stroke risk reduction in patients with non-valvular AF.
Adam Hill
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