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Novartis Adds Companion Dx to Lumiracoxib Resubmission in Europe

By Bernadette Toner and Turna Ray

SAN FRANCISCO — A Novartis official said yesterday that the company has identified a genetic marker that it plans to market as a companion diagnostic for a COX-2 inhibitor that was previously withdrawn from several non-US markets due to liver toxicity issues.

Michael Little, global head of diagnostics development at Novartis Molecular Diagnostics, told attendees of the Molecular Medicine Tri-Conference here that the company has resubmitted the compound, in combination with the genetic marker, to European regulatory authorities for the treatment of osteoarthritis symptoms.

The compound, lumiracoxib, was approved in the EU in 2006, but was withdrawn from the market in several countries the following year in the wake of a handful of serious liver adverse events. The US Food and Drug Administration in 2007 issued a "not approvable" letter for the drug, which was originally marketed under the brand name Prexige.

Little said that the company's molecular diagnostics unit, which it launched last year, has been conducting biomarker studies for the drug and has identified a marker that can identify patients who should not receive it due to the risk of liver-related adverse events.

Little said that the resubmission of lumiracoxib could be the "first example" of a molecular diagnostic-based "drug rescue" in the industry.

A Novartis spokesperson said that the company submitted the compound and the genetic marker to the EU in December.

"The genetic biomarker can identify patients at risk of certain liver-related side effects from lumiracoxib and make them ineligible for therapy," the spokesperson explained via e-mail. "A risk mitigation system would be implemented to screen out [osteoarthritis] patients with the genetic biomarker and exclude them from lumiracoxib treatment."

At a separate conference on pharmacogenomics in Bethesda, Md., this week, Kevin Carl, Novartis' director of global drug regulatory affairs, said that Novartis submitted data on the biomarker last year under the FDA's Voluntary Exploratory Data Submissions program. FDA's VXDS program allows sponsors to submit and discuss genomic data associated with its products without regulatory repercussions.

Although he indicated that Novartis was planning to submit the drug with the aid of a genetic biomarker for marketing approval with regulatory authorities around the world, he did not specifically discuss a resubmission strategy with the FDA.

A more in-depth version of this story is available from GenomeWeb Daily news sister publication Pharmacogenomics Reporter.