Need for Monthly Liver Tests Seen With Exanta Anticoagulant Therapy

[Guest guest]

Need for Monthly Liver Tests Seen With Exanta Anticoagulant Therapy

By Ben Hirschler

MUNICH (Reuters) Aug 30 - Physicians using AstraZeneca's new oral

anticoagulant Exanta will need to monitor patients' liver enzymes for at

least the first six months to check for possible toxicity, an expert on the

drug said on Sunday.

" There will need to be monthly tests during the first six months, and should

(liver enzyme) levels start to rise, the tests should be done more often, "

said Professor Bertil Olsson of University Hospital, Lund, Sweden.

Olsson, a key investigator for clinical trials of Exanta, was talking to

reporters at the annual meeting of the European Society of Cardiology.

A U.S. Food and Drug Administration advisory panel will meet on September 10

to consider whether the drug should be recommended for approval.

In clinical studies, around 6% of patients experienced transient elevation

of liver enzyme levels.

Olsson said patients monitored for 2 years had not shown any further liver

problems and researchers were now collecting data extending out to 5 years,

although this will not be ready in time to be considered by the FDA panel.

Exanta is the first new oral anticoagulant since the introduction of

warfarin 60 years ago.

Even with a requirement for monthly liver tests, demand for Exanta could be

substantial because of the problems associated with warfarin.

Exanta is already on sale in Europe as a treatment to prevent thrombosis

after orthopaedic surgery, but the big commercial opportunity lies in

long-term use for stroke prevention.

The FDA's Cardiovascular and Renal Drugs Advisory Committee will consider

both uses of the drug at the September 10 meeting.

European Society of Cardiology Congress 2004

[Guest guest]

Need for Monthly Liver Tests Seen With Exanta Anticoagulant Therapy

By Ben Hirschler

MUNICH (Reuters) Aug 30 - Physicians using AstraZeneca's new oral

anticoagulant Exanta will need to monitor patients' liver enzymes for at

least the first six months to check for possible toxicity, an expert on the

drug said on Sunday.

" There will need to be monthly tests during the first six months, and should

(liver enzyme) levels start to rise, the tests should be done more often, "

said Professor Bertil Olsson of University Hospital, Lund, Sweden.

Olsson, a key investigator for clinical trials of Exanta, was talking to

reporters at the annual meeting of the European Society of Cardiology.

A U.S. Food and Drug Administration advisory panel will meet on September 10

to consider whether the drug should be recommended for approval.

In clinical studies, around 6% of patients experienced transient elevation

of liver enzyme levels.

Olsson said patients monitored for 2 years had not shown any further liver

problems and researchers were now collecting data extending out to 5 years,

although this will not be ready in time to be considered by the FDA panel.

Exanta is the first new oral anticoagulant since the introduction of

warfarin 60 years ago.

Even with a requirement for monthly liver tests, demand for Exanta could be

substantial because of the problems associated with warfarin.

Exanta is already on sale in Europe as a treatment to prevent thrombosis

after orthopaedic surgery, but the big commercial opportunity lies in

long-term use for stroke prevention.

The FDA's Cardiovascular and Renal Drugs Advisory Committee will consider

both uses of the drug at the September 10 meeting.

European Society of Cardiology Congress 2004

[Guest guest]

Need for Monthly Liver Tests Seen With Exanta Anticoagulant Therapy

By Ben Hirschler

MUNICH (Reuters) Aug 30 - Physicians using AstraZeneca's new oral

anticoagulant Exanta will need to monitor patients' liver enzymes for at

least the first six months to check for possible toxicity, an expert on the

drug said on Sunday.

" There will need to be monthly tests during the first six months, and should

(liver enzyme) levels start to rise, the tests should be done more often, "

said Professor Bertil Olsson of University Hospital, Lund, Sweden.

Olsson, a key investigator for clinical trials of Exanta, was talking to

reporters at the annual meeting of the European Society of Cardiology.

A U.S. Food and Drug Administration advisory panel will meet on September 10

to consider whether the drug should be recommended for approval.

In clinical studies, around 6% of patients experienced transient elevation

of liver enzyme levels.

Olsson said patients monitored for 2 years had not shown any further liver

problems and researchers were now collecting data extending out to 5 years,

although this will not be ready in time to be considered by the FDA panel.

Exanta is the first new oral anticoagulant since the introduction of

warfarin 60 years ago.

Even with a requirement for monthly liver tests, demand for Exanta could be

substantial because of the problems associated with warfarin.

Exanta is already on sale in Europe as a treatment to prevent thrombosis

after orthopaedic surgery, but the big commercial opportunity lies in

long-term use for stroke prevention.

The FDA's Cardiovascular and Renal Drugs Advisory Committee will consider

both uses of the drug at the September 10 meeting.

European Society of Cardiology Congress 2004

[Guest guest]

Need for Monthly Liver Tests Seen With Exanta Anticoagulant Therapy

By Ben Hirschler

MUNICH (Reuters) Aug 30 - Physicians using AstraZeneca's new oral

anticoagulant Exanta will need to monitor patients' liver enzymes for at

least the first six months to check for possible toxicity, an expert on the

drug said on Sunday.

" There will need to be monthly tests during the first six months, and should

(liver enzyme) levels start to rise, the tests should be done more often, "

said Professor Bertil Olsson of University Hospital, Lund, Sweden.

Olsson, a key investigator for clinical trials of Exanta, was talking to

reporters at the annual meeting of the European Society of Cardiology.

A U.S. Food and Drug Administration advisory panel will meet on September 10

to consider whether the drug should be recommended for approval.

In clinical studies, around 6% of patients experienced transient elevation

of liver enzyme levels.

Olsson said patients monitored for 2 years had not shown any further liver

problems and researchers were now collecting data extending out to 5 years,

although this will not be ready in time to be considered by the FDA panel.

Exanta is the first new oral anticoagulant since the introduction of

warfarin 60 years ago.

Even with a requirement for monthly liver tests, demand for Exanta could be

substantial because of the problems associated with warfarin.

Exanta is already on sale in Europe as a treatment to prevent thrombosis

after orthopaedic surgery, but the big commercial opportunity lies in

long-term use for stroke prevention.

The FDA's Cardiovascular and Renal Drugs Advisory Committee will consider

both uses of the drug at the September 10 meeting.

European Society of Cardiology Congress 2004