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FDA approves new indication for Pfizer/BMS' Eliquis

Oral anticoagulant gains US approval for deep vein thrombosis use

Pfizer BMS Eliquis apixabanan atrial fibrilation

Pfizer and Bristol-Myers Squibb have chalked up another approval for their oral anticoagulant Eliquis in the US, this time for the prevention of deep vein thrombosis in patients undergoing orthopaedic surgery.

Eliquis (apixaban) was first approved by the FDA towards the end of 2012 for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF), and the new indication significantly expands the potential patient population for the drug.

Use of Eliquis to prevent DVT and pulmonary embolism (PE) in patients undergoing hip and knee surgery is backed by the ADVANCE 1, 2 and 3 studies, which collectively enrolled around 12,000 patients.

"As the number of hip and knee replacement surgeries performed in the US continues to increase, the risk of DVT following these surgeries remains a concern for physicians," said Steve Romano, senior vice president and medicines development group head at Pfizer.

Pfizer and BMS estimate that around 700,000 total knee replacement surgeries and more than 330,000 hip replacement surgeries are performed in the US every year.

Eliquis will compete directly with Bayer/Johnson & Johnson's Xarelto (rivaroxaban), which was approved for DVT prophylaxis in orthopaedic surgery in 2011, in the US. Both drugs are also approved for DVT prevention in Europe.

Sales of Eliquis were slower than hoped in the early quarters, and Pfizer and BMS mobilised their efforts behind the drug in the latter half of 2013 with what Brian Daniels, BMS' senior vice president, global development and medical affairs, recently described as a "laser focus".

The approach hinges on educating cardiologists about the benefits of the drug, as well as implementing a direct-to-consumer (DTC) advertising campaign in the US, and the initiative seems to have had some impact.

For instance, Pfizer reported that Eliquis sales rose 124 per cent from the third to fourth quarters last year, while prescribing volumes rose 68 per cent in the US over the same period. The drug has also now been launched and secured reimbursement approval in every major market in Europe, according to BMS.

Meanwhile, the two companies are also trying to secure a broader marketing approval for treatment of DVT and PE in the US and Europe this year, which would help consolidate Eliquis' competitive position in the marketplace.

17th March 2014

From: Sales

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