FDA rejects painkiller Prexige
pharmafile | October 3, 2007 | News story | Sales and Marketing | reg, safety
Novartis has received a "not approvable" letter from the FDA for its painkiller Prexige because of concerns about potential liver problems in patients.
The drug is in the same class as Merck's Vioxx, which was withdrawn almost exactly three years ago because of serious cardiovascular side-effects – an episode which has since prompted the FDA to tighten up significantly its safety requirements for new and existing drugs.
Novartis says the FDA's response came in spite of a clinical trial database for Prexige of around 40,000 patients, one of the largest bodies of evidence for any drug in the class.
In terms of the drug's liver safety profile, the company says its data shows the number of patients with dangerously elevated liver enzymes is in line with other currently available NSAIDs.
But Australia's drug regulator was concerned enough about the drug's liver side-effects to withdraw the drug from use in the country in August.
The regulator says it had received eight reports of serious liver-related adverse reactions to the drug, including two deaths and two liver transplants.
In Europe, Novartis had to inform doctors of new restrictions on prescribing the drug, making it clear it should not be used in patients with current liver disease or those at risk because of their histories or other medication.
Meanwhile, another key new drug for Novartis, diabetes treatment Galvus, has also been held up in the US because of safety concerns. The product has already been approved for launch in Europe, but will not be re-submitted to the FDA until 2009.
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