FDA recommends Xarelto for new approval
pharmafile | September 12, 2011 | News story | Sales and Marketing | Xarelto, atrial fibrillation, stroke
FDA advisors have recommended Bayer and Johnson & Johnson’s Xarelto be approved in the US for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
The Advisory Committee’s recommendation is not binding, but if ratified by the FDA it would follow hot on the heels of Xarelto’s July approval for the prevention of deep vein thrombosis.
Bayer said a decision on Xarelto’s stroke indication is expected in early November after the Committee voted 9-2, with one abstention, in favour of Xarelto’s approval.
Data considered by the Committee included results from the pivotal, global, double-blind 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) clinical trial).
This showed that once-daily Xarelto (rivaroxaban) 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.
Bayer holds the marketing rights to Xarelto in all markets outside the US, where it will be promoted by Johnson & Johnson’s Janssen Pharmaceuticals.
“We are pleased with the committee’s recommendation and look forward to working with the FDA to help make this important therapy available in the US,” said Peter DiBattiste, global therapeutic area dead, cardiovascular and metabolism, Johnson & Johnson Pharmaceutical Research and Development.
European applications for Xarelto for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation as well as the treatment of deep vein thrombosis (DVT) and the prevention of recurrent DVT and pulmonary embolism have been submitted to the EMA.
The drug is part of a new generation of anticoagulants seeking to replace the 65-year old injectable warfarin.
Pfizer and partner BMS have already had their oral blood thinner Eliquis (apixaban) approved in the EU and Boehringer Ingelheim stole a march over both rivals in October last year when the FDA approved its Pradaxa (dabigatran etexilate), for stroke risk reduction in patients with non-valvular atrial fibrillation.
Analysts estimate that these new drugs will reach combined sales of $12 – $20 billion by 2020, with J&J and Bayer’s drug adding around $1.6 billion in annual US sales.
Dominic Tyer
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