Pfizer and BMS’ blood thinner Eliquis approved in Europe
pharmafile | May 23, 2011 | News story | Sales and Marketing | BMS, Eliquis, Pfizer, apixaban
Pfizer and Bristol-Myers Squibb’s eagerly anticipated blood thinner Eliquis has gained European approval.
A twice-daily oral Factor Xa inhibitor, Eliquis (apixaban) has gained an EU licence for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
The approval is based on impressive phase III results that proved the drug’s superiority over Sanofi’s widely used blood thinner Lovenox (enoxaparin) with fewer adverse events.
Olivier Brandicourt, president and general manager of primary care at Pfizer, said: “We are excited to bring this new agent to market in Europe and provide orthopedic surgeons with an option that will help them to prevent VTE in patients undergoing elective total knee or total hip replacement surgery.”
Beatrice Cazala, senior VP of commercial operations at Bristol-Myers Squibb, said: “We are confident that our shared resources and leadership in the treatment of cardiovascular disease will help make the European launch a success and continue to bring value to the development of Eliquis.”
This will be one of the biggest approvals for both firms and will help offset looming patent expiries that will greatly reduce revenues at both companies.
Eliquis is a part of a new generation of oral anticoagulants that are looking to replace warfarin, which has been the standard oral anti-clotting agent for both post-surgery prevention of VTE and atrial fibrillation prevention for over half a century.
Other drugs in this new class include Bayer’s Xarelto and Boehringer Ingelheim’s Pradaxa, which received FDA approval in October for stroke risk reduction in patients with non-valvular atrial fibrillation (AF).
Both drugs already are sold in Europe to prevent clots after hip and knee surgery.
Analysts say that if Pfizer and BMS sought to expand Eliquis’ licence into atrial fibrillation use peak sales could be pushed to over $2.5 billion a year..
Ben Adams
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