8 major FDA decisions, announcements for novel oral anticoagulants

The emergence of novel oral anticoagulants in recent years has provided clinicians with new therapeutic options for the prevention of stroke, intracranial hemorrhage and mortality in patients with atrial fibrillation.

Since the FDA approval of anticoagulants including dabigatran (Pradaxa, Boehringer Ingelheim), rivaroxaban (Xarelto, Janssen Pharmaceuticals) and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), several studies have indicated the drugs' noninferiority to treatment with warfarin, and recent expansions of treatment indications have allowed for the use of these drugs to treat conditions including deep vein thrombosis (DVT) and pulmonary embolism (PE). Edoxaban (Savaysa, Daiichi Sankyo) has yet to receive FDA approval, but has also yielded favorable results compared with warfarin in patients with AF.

Cardiology Today offers an overview of recent major FDA approvals, announcements and advisory committee decisions relevant to the new generation of anticoagulants.

FDA approves Pradaxa to treat DVT, PE

Boehringer Ingelheim announced that the FDA approved Pradaxa for the treatment of DVT and PE in patients who have been on a parenteral anticoagulant for 5 days to 10 days, and to reduce the risk for recurrent DVT and PE in previously treated patients. Read more

Eliquis approved to prevent DVT after hip, knee replacement surgery

The FDA approved Eliquis for the prophylaxis of DVT in patients who have had hip or knee replacement surgery. Read more

Advisory panel votes against Xarelto for treatment of ACS

The FDA’s Circulatory and Renal Drugs Advisory Committee voted 0-10, with one abstention, against recommending approval for Xarelto for the treatment of ACS over the course of 90 days. Read more

Daiichi Sankyo seeks FDA approval for Savaysa

Daiichi Sankyo is seeking approval for edoxaban, its investigational direct factor Xa inhibitor, for the treatment of PE and DVT, as preventive treatment for recurrent symptomatic venous thromboembolism, and for the reduction of risk for stroke and systemic embolic events among patients with nonvalvular AF. Read more

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FDA denies new indication for Xarelto

Janssen Research and Development announced that the FDA issued complete response letters regarding supplemental new drug applications for the use of Xarelto to reduce the risk for secondary CV events in patients with ACS and to reduce the risk for stent thrombosis in the same patients, in combination with standard antiplatelet therapy. Read more

FDA to assess safety of Pradaxa for nonvalvular AF

The FDA announced plans to conduct a safety assessment of Pradaxa, as compared with warfarin, for the treatment of patients with nonvalvular AF. Read more

Factor Xa inhibitor antidote designated breakthrough therapy

Portola Pharmaceuticals has announced that the FDA designated its investigational Factor Xa inhibitor, andexanet alfa, a breakthrough therapy. The drug is a first-in-class agent intended for patients who experience uncontrolled bleeding or require emergency surgery after treatment with Factor Xa inhibitors. Read more

Stent thrombosis indication for rivaroxaban declined

The FDA issued a complete response letter to Jannsen Pharmaceuticals that declined the request of the manufacturer to expand the indication of Xarelto to include the reduction of stent thrombosis in patients with ACS. Read more