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Posted: Tue Aug 26, 2008 2:06 am Post subject: New labelling
Biogen, FDA work to amend Multiple Sclerosis drug Tysabri's label 26 August 2008
A warning on Biogen Idec and Elan Corp's drug, Tysabri, has been revised following two recent reports of a potentially fatal brain infection, Biogen said.
The company plans to provide an update on the two patients on today at a medical conference in Madrid, Biogen spokeswoman Shannon Altimari also said.
Still, both companies were down sharply since they disclosed on July 31 that two more patients had developed progressive multifocal leukoencephalopathy, a brain disorder known as PML that is usually fatal.
The FDA, in an alert to doctors posted on Monday on its website, said the agency had been told of the two newest PML cases and was "working with the manufacturer to amend the product labeling."
Biogen's Altimari said prescribing instructions were changed last week to note that PML had been reported in patients using Tysabri as their sole treatment for multiple sclerosis.
The two recent cases involved patients in Europe who were using Tysabri as "monotherapy," or stand-alone treatment, for more than a year.
"While the two patients who developed PML were on monotherapy, the FDA still believes that Tysabri monotherapy may confer a lower risk of PML than when Tysabri is used together with other immunomodulatory medications," the FDA said. Previously, PML had been seen in patients using Tysabri with other medicines to control MS. Tysabri was withdrawn in 2005 amid three cases of PML, but returned to the market in 2006 with warnings and tougher prescription guidelines.
New language on Tysabri's label notes that PML incidence "appears to be lower" with monotherapy, but adds "the number of cases is too few and the number of patients treated too small to reliably conclude that the true risk of PML is lower in patients treated with Tysabri alone."
The changes "were made with the FDA's concurrence," agency spokeswoman Sandy Walsh said late on Monday.
About 39,000 patients have been treated with Tysabri worldwide, with about 12,000 patients using the drug for at least a year, the FDA said.
Tysabri, known generically as natalizumab, is approved for treating multiple sclerosis and the bowel disorder Crohn's disease. It is given by injection.
Biogen plans to provide an update on the condition of the two patients with PML at the European Federation of Neurological Societies in Madrid on Tuesday, Altimari said.
Joined: Jul 28, 2005 Posts: 1199 Location: Sydney, Australia
Posted: Tue Aug 26, 2008 3:52 am Post subject:
Quote:
PML is lower in patients treated with Tysabri alone
ahhh... is this just me or does this sound like a public image statement? I think most people would be concerned regarding the risk of PML over no Tysabri, rather than just when you combine it. Especially now that there have been cases in monotherapy.
Joined: May 04, 2006 Posts: 3323 Location: Mid-Michigan
Posted: Tue Aug 26, 2008 4:28 pm Post subject:
CureOrBust wrote:
is this just me or does this sound like a public image statement? I think most people would be concerned regarding the risk of PML over no Tysabri, rather than just when you combine it. Especially now that there have been cases in monotherapy.
I'm not so sure and I've found that interesting Cure. Since these last two PML cases I've gone out of my way to read the blogs, logs and diaries of people on Tysabri and it has seemed pretty obvious that it's not scaring many people off, and that the people who are finding benefit on Tysabri feel that the benefit outweighs the risk of PML. Not to hint that time won't prove them wrong, but that's what the situation seems to be now.
It seems pretty well established that the JC virus is present in the brains of most people and that it is an opportunistic infection which only rarely is not kept under control by the immune system.
For the JC virus to be able to take advantage of the situation requires immune system over suppression over a long period, and at this point it seems the big question is "is the current dosage of Tysabri mono over suppressing the immune system and with things being as they are, is two years the beginning of what will escalate into a huge problem, or are things going to plateau at an occasional case of PML, which is terrible, but should reasonably be expected?"
I have no idea what the answers are, but that's what I'm wondering.
Bob _________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
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