FDA approves BMS/Pfizer’s Eliquis in DVT and PE

The US FDA yesterday backed a new blood clot indication for the Bristol-Myers Squibb (BMS) and Pfizer's oral anticoagulant Eliquis.

The regulator approved the use of Eliquis (apixaban) in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk of recurrent incidences of these conditions.

DVT is a blood clot in a vein, usually in the lower part of the body, while PE is a clot that blocks blood flow to the lung. DVT can progress to PE and the two life-threatening conditions are collectively known as venous thromboembolism (VTE).

The approval opens a wide new market to BMS and Pfizer with about 900,000 Americans thought to be affected by either DVT or PE each year.

There is existing competition in the field, however, as both Pradaxa (dabigatran), marketed by Boehringer Ingelheim, and Xarelto (rivaroxaban), marketed by Johnson & Johnson and Bayer, are available in a similar indication.

All three drugs are battling it out in the emerging oral anticoagulant market, which has been growing rapidly over the past couple of years as doctors look to safer, more convenient blood-thinning treatments such as warfarin.

Xarelto has been available in the US in the treatment of DVT and PE since 2012 while Pradaxa won approval in April this year.

All these treatments are also available in other indications in the US. In addition to the DVT and PE indications, Pradaxa is approved to reduce the risk of stroke and blood clots in people with atrial fibrillation.

Xarelto, and now Eliquis, are also approved in these indications as well as for the prevention of DVT in patients who have undergone hip or knee replacement surgery.

Another rival is emerging in the form of Daiichi Sankyo's edoxaban. The drug has been available in Daiichi's home nation of Japan since 2011 but the company is looking to extend its use on a global scale. At the beginning of 2014 Daiichi filed for both US and EU approval of the drug in the management of patients with atrial fibrillation and VTE.