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Biogen: Tysabri patients have PML
Biogen Idec CEO James Mullen predicted it, and now it's happened: Two Tysabri patients have come down with the potentially fatal brain infection, progressive multifocal leukoencephalopathy, or PML, that caused Biogen to withdraw the multiple-sclerosis treatment back in 2005. This time around, though, the company doesn't plan to pull the med or further restrict it.
As you know, Tysabri was allowed back onto the market in July 2006 under a strict risk-management program. Since then, 31,600 patients have started on the drug, and Biogen (and its partner Elan) won an additional indication for Crohn's disease. Mullen had been predicting that 100,000 patients would be using Tysabri by 2010, with quarterly sales of $250 million or better by the end of this year.
It's unclear whether this news will decimate those sales. Investors seem to think so; both Biogen and Elan have seen their shares drop precipitously this morning. And the fact that the sickest PML patient--who's now hospitalized--was only taking Tysabri for 14 months, because the duration of treatment seems to be a factor in the disease. (Previous PML patients had used Tysabri for some two years before discovering they had it.) This patient had used other MS drugs before taking Tysabri, which also appears to be a risk factor. The other patient, who's at home and ambulatory, had been on Tysabri for 18 months, and hadn't used any other MS treatments before.
But patients know about the PML risks before they go on Tysabri; the risk-management program makes sure of that. And so far, the number of PML cases appears to be in line with the statistical risk listed on the drug's label. So we'll have to watch the scrip numbers to see whether verification of that risk deters patients.
- read the Wall Street Journal article
- see the story in the Boston Herald
Related Articles:
Biogen CEO: Tysabri to reach $1B in 2008
No new PML cases for Tysabri
Watchdog endorses use of Tysabri for severe MS
After reintroduction, Tysabri builds patient base
FDA allows Tysabri back on market
Comments
By Anonymous | Posted 6:27pm | August 5, 2008
This is a risk that we know about, the FDA said 1:1,000 risk of PML. There are >32,000 patients currently taking Tysabri with almost 50,000 exposures. The patients are more afraid of Tysabri being taken off the marketthan they are of PML for the most part. This therapy can dramatically help in refractive and even naive MS patients. The risk benefit ratio still is on Tysabri's side.
By Anonymous | Posted 6:58am | July 28, 2009
The problem is that patients do not receive sufficient information to be able to make their own risk/benefit decisions. As far as any Tysabri pateint knows many might have already received the virus and be cueing for fulfilling pml statistical forecasts. For some this possibility might be preferable to life without Tysabri but not for those who do not profit from it. So can anyone give honest accounts of dropout from Tysabri?
By J. Cook | Posted 9:33pm | August 3, 2009
I completely disagree that "patients do not receive suffience information." Biogen gives a LOT of information -- MOST of it focused entirely on the risk of PML. For me, I know everything I need to know; the reality is, I'm willing to take the risk of PML for the chance that my MS might slow down its recent progression.
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