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US : FDA Approves Eliquis For DVT And PE
US : FDA Approves Eliquis For DVT And PE

US : FDA Approves Eliquis For DVT And PE

The FDA has approved a supplemental new drug application for apixaban, an oral selective Factor Xa inhibitor, for the treatment of deep vein thrombosis and pulmonary embolism, as well as for reduction of the risk for recurrence of those conditions after initial therapy.

Based on data from the global AMPLIFY and AMPLIFY-EXT studies, Eliquis was also cleared for the reduction in the risk of recurrent DVT and PE following initial therapy.

A blood clot in a vein, usually in the lower leg, thigh, or pelvis, DVT partially or totally blocks the flow of blood, while PE is a blood clot blocking one or more vessels in the lungs and can lead to sudden death.

Jointly known as VTE, DVT and PE are estimated to affect nearly 900,000 US citizens every year.

Bristol-Myers Squibb Specialty Development head Douglas Manion said: “Eliquis offers oral dosing, no routine coagulation testing, and does not require the use of a parenteral anticoagulant or bridging during initiation.”

Pfizer senior vice-president and Global Innovative Pharmaceuticals Medicines Development Group head Steve Romano said: “DVT, which may lead to PE, can be a serious medical condition, with PE requiring immediate medical attention for treatment.

“Once a VTE has occurred, approximately 33 percent of patients are at risk of a recurrence within 10 years.”

The randomized, double-blind trial, AMPLIFY study included patients with confirmed symptomatic DVT or PE, who were given 10mg Eliquis twice daily for one week followed by 5mg twice daily for six months.

Eliquis demonstrated efficacy comparable to standard of care in treating DVT and PE patients for the primary efficacy composite endpoint of recurrent, symptomatic VTE, or VTE-related death.

In AMPLIFY, the discontinuation rate due to bleeding events was found to be 0.7% in the Eliquis-treated patients compared to 1.7% in enoxaparin/warfarin-treated patients.

The subjects received initial enoxaparin treatment for at least five days, overlapped by warfarin therapy orally for six months before the trial.

Also called apixaban, Eliquis is an oral selective Factor Xa inhibitor, and decreases thrombin generation and blood clot formation by inhibiting Factor Xa, a key blood-clotting protein.

Agencies/Canadajournal




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