Exanta Launched in Germany

[JimChicago]

From:
http://www.drugresearcher.com/news/news-NG.asp?id=53104
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First oral thrombin inhibitor reaches market

25/06/2004 - AstraZeneca?s anticoagulant Exanta (ximelagatran) has been launched in Germany, its first market worldwide, for the prevention of blood clots in patients undergoing hip or knee replacement surgery.

The drug is the first new anticoagulant to reach the market since the introduction of warfarin more than 60 years ago. It acts by inhibiting the clotting factor thrombin
Exanta has a number of advantages over warfarin, including that it can be administered as a fixed oral dose, has a rapid onset and offset of action and exhibits low potential for food and drug interactions. Furthermore, coagulation monitoring is not required with the new drug, reducing the burden of patient care.

While the initial indication is in orthopaedic surgery, the real pay-off for AstraZeneca will come if Exanta can gain approval in another indication - the prevention of stroke and other thromboembolic complications associated with atrial fibrillation (AF). It is currently under regulatory review in Europe for this indication.

The company has high hopes for the drug, and these are shared by market research firm Decision Resources. Last year, the latter forecasted that Exanta will revolutionise the prevention of stroke in cases of AF and that sales of the drug will reach more than $1.5 billion (?1.2bn) in 2007 and top $2.4 billion in 2012.

Meanwhile, a report by analysts at Morgan Stanley forecasts the global market for thrombosis treatments to increase from $5.1 billion in 2002 to $16.2 billion in 2010, with 65 per cent of this revenue growth expected to come from the US market.

The launch of Exanta in Germany follows the recent successful completion of the European Union?s Mutual Recognition Procedure, for which France acted as the reference member state.

Filings have also been submitted to the US Food and Drug Administration (FDA) at the end of December 2003 for use of Exanta in the prevention of VTE in patients undergoing knee replacement surgery, as well as for the prevention of stroke and other thromboembolic complications associated with AF and long-term secondary prevention of VTE.
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[Guest]

Keep in mind that no studies have yet been reported on its use in animals with mechanical valves, let alone on people. It will be many years before it will be used in people with mechanical valves, if ever.

 

[JimChicago]

Keep in mind that no studies have yet been reported on its use in animals with mechanical valves, let alone on people. It will be many years before it will be used in people with mechanical valves, if ever.

I guess I'd be reluctant anyhow of trying this new medicine until many years have shown what side effects too it might cause and whether it would work.

But Al I was wondering about this new medicine in conjunction with your comments I've read about Heparin. As I recal I believe you explained that heparin had never been subject to any double blind studies on whether it was effective to prevent clots with metal valves. So I was wondering if you think that something like Exanta may possibly in a similar way ever begin to be used for special circumstances if for any reason a person couldn't take warfarin?

 

[Guest]

Once a drug is on the market a doctor can prescribe it for anything. An insurance company may (and often does) refuse to pay for the prescription if it is for an unapproved use. There could also be a liability problem if, for instance, a doctor prescribed warfarin for bedwetting when there is no evidence that it works for that problem.

Heparin is a special case. I was on the market before the current regulations went into effect. Warfarin was too, but before it went generic they ran studies to prove that it worked.

There is currently a power struggle going on over whether or not digoxin liquid works for children. The FDA says that the company has never proven its effectiveness and that they must do so or it will be removed from the market. The manufacturer says that it would cost them more than it is worth to run the studies on a fairly inexpensive generic drug so they ignored the FDA. If the FDA follows through there may be a a bunch of children die because they depend on the drug. If that happens look for Ralph Nader to be elected president!!!!!