US watchdog rejects Novartis painkiller

The rejection of the Prexige drug is the latest in a series of setbacks for Novartis

Swiss pharmaceutical company Novartis has failed to gain approval for its controversial Prexige painkiller from United States regulators.

This content was published on September 27, 2007 - 10:36

The decision comes after the Australian authorities last month banned the drug, which is approved in more than 50 countries across the world.

The company said it received a letter from the US Food and Drug Administration (FDA) - as expected - denying it approval for Prexige.

"Novartis will continue discussions with the FDA and believes Prexige a valuable treatment option for appropriate patients with osteoarthritic pain," the company said in a statement on Thursday.

Analysts had doubted the drug, a so-called COX-2 inhibitor, would get to markets in the US after Australian regulators withdrew the product over concerns of serious liver side effects associated with the use of the drug, including two deaths and two liver transplants.

Prexige had modest sales of $52 million (SFr61 million) in the first half of the year.

A request for approval of the drug on the Swiss market is still pending.

Setbacks

In August Novartis informed doctors in Europe of new restrictions on prescribing Prexige, saying it should not be used in patients with current liver disease or those at risk because of their histories or other prescribed medicines taken.

COX-2s have been under a cloud since the withdrawal three years ago of the Vioxx drug, produced by Merck, after studies found it raised heart attack risks.

Novartis, which has its headquarters in Basel, has been plagued by a number of drug setbacks this year.

The launch of a diabetes drug was delayed because of safety concerns and a bowel drug was withdrawn from US shelves in March.

swissinfo with agencies

Key facts

Novartis business figures 2006:

Net profit: $7.20 billion
Full-year sales: $37.02 billion
Operating income: $8.2 billion

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In brief

Basel-based Novartis was created in 1996 through the merger of Ciba-Geigy and Sandoz.

The company is organised into four divisions: pharmaceuticals (prescription medicines), vaccines and diagnostics, Sandoz, (generic prescription drugs) and consumer health.

The name Novartis is derived from the Latin novae artes, meaning "new skills".

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