AstraZeneca Exanta For Prevention Of Thromboembolism Goes To Cmte. In September

The company is also seeking an indication for longer term secondary prevention of venous thromboembolism. Phase III results show oral direct thrombin inhibitor is equal to or better than warfarin, without dose adjustment.

AstraZeneca's Exanta will be reviewed for prevention of stroke and thromboembolism by FDA's Cardiovascular & Renal Drugs Advisory Committee at a Sept. 10 meeting.

AstraZeneca is seeking indications for Exanta (ximelagatran) for the prevention of thromboembolism in patients undergoing knee replacement surgery and the prevention of stroke and other thromboembolic complications associated with atrial fibrillation.

An indication for longer term secondary prevention of venous thromboembolism after standard treatment of an episode of acute venous thromboembolism is also included in the application.

[Editor's Note: To watch a webcast or order a video/DVD of this meeting, go to FDAAdvisoryCommittee.com.]

AstraZeneca submitted the NDA (21-686) for the oral thrombin inhibitor on Dec. 23, 2003, giving the application an estimated user fee deadline of Oct. 23.

Exanta has been touted as a potential blockbuster. The drug is a direct thrombin inhibitor that can be delivered orally, while other blood thinning agents such as Aventis' Lovenox (enoxaparin) must be given intravenously.

Exanta may also be given in a fixed dose and does not require coagulation testing, as with Bristol-Myers Squibb's Coumadin (warfarin).

In a Phase III trial of 2,303 patients who had undergone total knee replacement surgery, 1,949 patients had venography adequate for evaluation or confirmed symptomatic events.

Of those patients, the incidence of total venous thromboembolism and death for Exanta patients was 22.5% and 31.9% for warfarin patients.

In the 3,407 SPORTIF III trial in atrial fibrillation patients, Exanta 36 mg b.i.d. was equal to dose-adjusted warfarin in preventing strokes and systemic embolic events.

- Danielle Foullon