Novartis Withdraws Joicela Marketing Application in Europe
Novartis AG (NOVN) withdrew its application to market the Joicela pain pill in the European Union because the Swiss company wasn’t able to provide information to regulators in the time allowed.
Joicela was intended to be used to relieve pain in patients with osteoarthritis of the knee and hip who don’t carry a specific genetic marker, the European Medicines Agency said in a statement today. The withdrawal won’t bias the regulator against a subsequent application for the product, the agency said.
The EU filing was the second attempt by Novartis, Europe’s second-largest drugmaker by sales, at re-introducing the drug. The Basel-based company planned to re-submit the treatment, which belongs to a group of painkillers known as COX-2 inhibitors, to U.S. regulators in 2009 along with a genetic test to detect patients prone to liver damage, Novartis said at the time.
The U.S. Food and Drug Administration said in September 2007 that it couldn’t approve the treatment, also known as lumiracoxib or Prexige, for patients suffering from osteoarthritis because studies showed too high a rate of liver damage. European regulators halted sales of the drug months later.
The application withdrawal “has nothing to do with biomarkers or genetic tests,” Eric Althoff, a spokesman for Novartis, said in a telephone interview. “COX-2s remain a challenging environment.”
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