Swiss drug giant Novartis has retracted an application in Europe to put its painkiller Joicela back on the market, after the drug was pulled from shelves in 2007.
The company’s hopes to revive Joicela (lumiracoxib), which was originally called Prexige, have now been quashed, at least in the near future, following a request by European regulators for more data.
The European Medicines Agency said it has been notified by Novartis that its marketing application to sell the drug as a treatment for osteoarthritis of the knee and hip in certain patients has been withdrawn, as the company felt it was unable to meet a request for additional data within the allowed timeframe.
Sales of Joicela – which belongs to the same class as Merck & Co’s disgraced COX-2 inhibitor Vioxx (rofecoxib), pulled from the market in 2004 because of its cardiovascular risk – were suspended in 2007 after an investigation revealed an increase in serious liver reactions with the licensed dose, sometimes in as little as a month after treatment was started.
Novartis refiled the drug back in 2009, suggesting its use alongside a genetic test to sift out those patients most prone to liver damage to reduce the risk.
There were hopes that a newborn Joicela could help Novartis claw back some of the sales lost to generic competition hitting some of its big earners – including top seller Diovan (valsartan), turnover of which dropped 3% to $1.48 billion in the first quarter due to generic competition in Spain, Canada and Brazil – though this seems unlikely now in the near-term.
