Novartis explores genetic test for side effects

Two years ago the FDA rejected Novartis' Cox-2 inhibitor Prexige on concerns that the drug would cause liver damage in some patients. The osteoarthritis pain drug was once predicted to have yearly sales of $1 billion or more, but has managed only a fraction of that.

But Novartis is hoping to revive the drug with the help of a genetic test that would determine which patients would be at risk for liver damage, and which could safely take the drug. Such a companion test would be the first of its kind. While some drugs, like Herceptin, use genetic testing to determine if the treatment will work for a given patient, there are currently no drugs that feature tests for side effects. "This is a very real opportunity now," Michael Nohaile, the head of Novartis's molecular diagnostics business, told Bloomberg. "We already have an agreement from many authorities that the data are good and that they are excited about it. This could be a launch this year or next." The Prexige side effect test would be the first genetic test developed by Novartis diagnostic unit since it was founded in 2008.

Convincing doctors and patients that Prexige is safe is essential to the drugs success, but Novartis is facing an uphill battle. The infamous Vioxx, another Cox-2 inhibitor, was pulled from the market in 2004 when it was discovered that the drug was linked to an increase in heart attacks and stroke.

- here's the Bloomberg article

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