More bad news for Prexige, and NVS should now just
pull the drug everywhere, IMO. A baseball analogy is
walking a good hitter intentionally after the count
reaches 2-0 and there are runners in scoring position.
(The “runners” in this case are the trial lawyers.) The
actual data on which the Prexige suspensions are based
are hardly robust, but that’s no longer the issue.
reuters.com
>>
UK, Germany, Austria Suspend Prexige
Mon Nov 19, 2007 10:48am EST
By Ben Hirschler
LONDON, Nov 19 (Reuters) - Britain, Germany and Austria on Monday suspended the sale of Novartis AG's painkiller Prexige due to safety concerns about possible liver damage.
The move, which follows similar action in Australia and Canada, is a blow to remaining hopes that the drug might become a significant seller for the Swiss healthcare group.
Britain's Medicines and Healthcare products Regulatory Agency said a review of the latest data on the safety of Prexige, also known generically as lumiracoxib, showed an increased number of serious liver reactions.
In some cases this affected patients taking the medicine for less than one month, the UK watchdog said.
Prexige was initially viewed as an important future blockbuster for Novartis. But the fate of the product -- a so-called COX-2 inhibitor -- has been under a cloud since the withdrawal of Merck & Co Inc's (MRK) similar drug Vioxx in 2004, which prompted increased scrutiny of the drug class.
Although approved in Europe and some other countries, Prexige has never been cleared for sale in the United States and the Food and Drug Administration issued a "non-approvable" letter for the product in September.
Novartis said it would continue discussions with health authorities about the future of the medicine, adding it believed Prexige was still a valuable treatment option for patients suffering pain caused by osteoarthritis.
Prexige is available in some European countries after winning approval in October 2006 but it has never become a major seller, generating net sales of just $8 million in Europe in the first nine months of 2007.
In addition to Britain, Germany and Austria, Prexige is also marketed in Belgium, Cyprus, Hungary, Malta, Portugal and Sweden.
Novartis said it was possible that other European countries would also decide to suspend the drug while the European Medicines Agency conducts a regulatory review. The agency is expected to make a decision on the product in December.
The Basel-based drugmaker said in a statement that the latest analysis of patients taking the 100 milligram once-daily form of Prexige showed there had been nine severe cases of liver damage reported worldwide.
That is equivalent to a rate of 5.19 events per 100,000 patient-years, which Novartis argued was within the rate to be expected for non-steroidal anti-inflammatory drugs (NSAIDs) like Prexige.
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