8 major FDA decisions, announcements for novel oral anticoagulants

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

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

Source: www.healio.com