FDA Declines To Approve Novartis’ Prexige
3 CommentsBy Ed Silverman // September 27th, 2007 // 6:29 am
This is hardly surprising. Dan Vasella, the drugmaker’s ceo, earlier this month himself told analysts he didn’t expect the FDA to approve Prexige, not after the Cox-2 painkiller last month was blamed for deaths and liver transplants in Australia. The drug was subsequently withdrawn there.
Novartis, however, is undaunted. “Many patients cannot tolerate the gastrointestinal side effects associated with NSAID pain treatments, such as those suffering from ulcers or who are being treated with anti-coagulants like warfarin,” Jim Shannon, the drugmaker’s global head of development, says in a statement. “We believe Prexige remains an important therapy for appropriate patients with osteoarthritic pain, and we will continue discussions with the FDA.”
Last month, Novartis told doctors in Europe to test for serious liver disease in patients taking Prexige and warned those already suffering or at risk of the illness of taking the drug. To seek FDA approval, Novartis presented data on about 40,000 patients to the FDA and studied the liver profile of those taking Prexige for 12 months at the regulator’s request. But to no avail. The FDA, by the way, also delayed approval of the drugmaker’s Galvus diabetes drug.
Reality
Actually, I guess I’m somewhat surprised. The hepatic toxicity was only at the higher doses, and Prexige actually has a very good blood pressure profile as I recall, unlike some other COX-2s and NSAIDs, as well as a CV profile comparable to naproxen and better than ibuprofen.
I think the issue here is that the FDA is spooked about this class, and doesn’t want another Vioxx/VIGOR fiasco on its hands.
There is a genuine need for these drugs in the right patient population — those who require long-term analgesic treatment who can’t tolerate traditional NSAIDs, which is not an insignificant number of people, and GI toxicity is not an insignificant outcome.
Pfizer’s got to be pretty happy about this — they own the market (in the US).
Ramiro da Fonseca
So, what is really behind all this? It seems more like a financial war, where the patients are in second plan. In my oppinion Prexige should be out of the market for good. There will allwais remain some doubts, not only from the doctors, but also from the patients. Clearly Novartis was not abble to handle this problem
jason
Reality,
I completely agree with your comments. I wish someone would come up with an NSAID that has no adverse renal effects. To me that is more dangerous than the GI risk that can be mitigated with gastroprotection.