Xarelto gains new licences in UK
pharmafile | December 20, 2011 | News story | Sales and Marketing |
Bayer’s anticoagulant pill Xarelto has gained two new lucrative licences, and is now available in the UK to prevent stroke and DVT for certain patients.
The drug has been approved by the European Commission and can now be used in the UK to prevent stroke on-CNS systemic embolism in adult patients with non-valvular atrial fibrillation (AF), with one or more risk factors for stroke, including congestive heart failure and hypertension.
It is also now licensed for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism following an acute DVT.
Xarelto is already approved in the UK to help prevent venous thromboembolism in patients undergoing elective total hip or knee replacement surgery, and was recommended by NICE for this indication in April 2009.
The drug is a once-daily factor Xa inhibitor and will cost £2.10 per tablet across both indications.
It will now compete with Boehringer’s Pradaxa (dabigatran), a twice-daily oral direct thrombin inhibitor.
This drug is also licensed to treat prevent stroke and systemic embolism in patients with atrial fibrillation, as well as for the prevention of venous thromboembolism in patients who have elective knee or hip surgery.
The cost per day per patient for Pradaxa, based on the recommended dosage, is £2.52 for either the 110mg or 150mg dose.
Pradaxa recently gained a NICE recommendation for this licence, and its price was deemed a cost effective use of NHS resources.
Xarelto will now have to undergo a separate NICE appraisal for these new licences, and the pricing watchdog is set to make its final decision on whether to recommend the drug for NHS funding in May 2012.
Growing market for stroke prevention drugs
Pfizer and Bristol-Myers Squibb’s Eliquis (apixaban) is also seeking a licence to prevent stroke risk in AF patients, and expects a decision from the EMA in early 2012.
It has already been launched in the UK earlier this year after being approved for the prevention of venous thromboembolic events, in adult patients who have undergone elective total hip or knee replacement surgery.
All three drugs are in competition to take a slice of the new anticoagulation market, which is looking to replace the cheaper, but much older treatments of warfarin, heparin and aspirin.
They are expected to make blockbuster sales, with Xarelto set to make $2 billion in peak annual sales, with Eliquis – which is believed to be the most effective of the three – predicted to bring in $4.2 billion, and Pradaxa $2.6 billion.
Ben Adams
