PML 3 more cases

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

PML 3 more cases

Postby scorpion » Tue Sep 22, 2009 11:16 am

FDA confirms 3 new infections linked to Tysabri

(AP) – 4 hours ago

NEW YORK — The Food and Drug Administration says it confirmed three new cases of a potentially lethal brain inflammation linked to the multiple sclerosis drug Tysabri.

There have been 13 reported cases of progressive multifocal leukoencephalopathy, or PML, since mid-2006. The reports are the first confirmed new cases since June. While the disease is rare, the FDA says the risk appears to increase as patients remain on Tysabri.

Tysabri is marketed by Biogen Idec Inc. and Elan Corp. PLC, for multiple sclerosis and Crohn's disease. All the PML cases are linked to its use in multiple sclerosis.

The drug was approved in November 2004 and pulled from the market the next year due to PML reports. It was reintroduced in July 2006, and Biogen said it is used by 43,000 patients.
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Postby turbotaguy » Thu Sep 24, 2009 7:53 am

Now that Biogen is no longer controlling the release of PML cases I expect more cases to be reported. I think Biogen probably pushed back on potential cases to make sure they were real (like your insurance company denying a claim the firs time through).

I bet now that the FDA is releasing information it will be more "live".
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Re: PML 3 more cases

Postby HarryZ » Thu Sep 24, 2009 11:07 am

scorpion wrote:FDA confirms 3 new infections linked to Tysabri

(AP) – 4 hours ago

NEW YORK — The Food and Drug Administration says it confirmed three new cases of a potentially lethal brain inflammation linked to the multiple sclerosis drug Tysabri.

There have been 13 reported cases of progressive multifocal leukoencephalopathy, or PML, since mid-2006. The reports are the first confirmed new cases since June. While the disease is rare, the FDA says the risk appears to increase as patients remain on Tysabri.


Prior to this update, A. Jefferies and Company indicated their take on the risks of getting PML while using Tysabri:

1 in 2490 with 12 infusions
1 in 1400 with 18 infusions
1 in 680 with 24 infusions

Now we have 3 more cases...I wonder what that does to the risk numbers?

Harry
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Postby 10yearsandstillkicken » Thu Sep 24, 2009 12:27 pm

Was the country of each of the 3 reported? If I am remembering correctly (and I have serious CRS) of the previous 11 , 8 or 9 were not in the US. If all of the latest are also non US (seems like I saw at least 2 was non US), isn't that odd? Seems like it should be important not only to non US patients but what about that is causing the discrepency. I have been on this for over a year as of June/July. I'd like to know what is really going on.
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Postby HarryZ » Thu Sep 24, 2009 12:47 pm

10yearsandstillkicken wrote:Was the country of each of the 3 reported? If I am remembering correctly (and I have serious CRS) of the previous 11 , 8 or 9 were not in the US. If all of the latest are also non US (seems like I saw at least 2 was non US), isn't that odd? Seems like it should be important not only to non US patients but what about that is causing the discrepency. I have been on this for over a year as of June/July. I'd like to know what is really going on.


The new report didn't stipulate what country these 3 new PML cases were from. The reasons for the discrepency can only be speculative at this point but it appears that the longer one is on Tysabri, the higher the risk.

Harry
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Postby RuSmolikova » Thu Sep 24, 2009 2:11 pm

The one diagnosed in August is from Switzerland and another two (the September ones) are from USA and Germany.
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Postby 10yearsandstillkicken » Fri Sep 25, 2009 8:33 pm

The length of treatment certainly appears to be a major factor. Was tysabri released back on the market in Europe before the US? So there are more who have been on it for a longer period of time? 75% seems to be more than a coincidence even with a small number in the sample.
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Postby RuSmolikova » Sat Sep 26, 2009 2:03 am

FDA Information on Natalizumab (marketed as Tysabri)
Updated Information: [9/2009]
The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008. From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. Of these, four cases were patients in the United States (U.S.). There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn’s disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease.
The risk for developing PML appears to increase with the number of Tysabri infusions received. The number of monthly infusions of Tysabri in the 13 patients who developed PML ranged from 12 to 35 infusions. The average number of infusions received before the diagnosis of PML was 25. There is minimal experience in patients who have received more than 35 infusions of Tysabri. The overall rate of developing PML with Tysabri therapy in patients who have received at least one infusion remains below one per 1,000 patients. Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.
At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program. All patients receiving Tysabri therapy in the U.S. must be enrolled in the TOUCH Prescribing Program. Under this program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections.
Last edited by RuSmolikova on Sat Sep 26, 2009 2:15 am, edited 3 times in total.
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Postby RuSmolikova » Sat Sep 26, 2009 2:08 am

The European Commission gave a permission to Tysabri´s comeback to the European market in the end of June 2006.
And the last case of PML is 40 yo lady from Germany who was on Tys for 24 moths.
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Postby brave » Sun Sep 27, 2009 11:12 pm

Is it known how many people WW are on Tysabri? then we would know if 13 dead relatively is high or not?

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Postby RuSmolikova » Sun Sep 27, 2009 11:50 pm

As of June 30, about 43,300 patients were taking Tysabri, with more than 30, 000 on it for more than a year, and about 10,000 on it for more than two years.
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Postby euphoniaa » Mon Sep 28, 2009 4:01 am

HarryZ wrote:
10yearsandstillkicken wrote:Was the country of each of the 3 reported? If I am remembering correctly (and I have serious CRS) of the previous 11 , 8 or 9 were not in the US. If all of the latest are also non US (seems like I saw at least 2 was non US), isn't that odd? Seems like it should be important not only to non US patients but what about that is causing the discrepency. I have been on this for over a year as of June/July. I'd like to know what is really going on.


The new report didn't stipulate what country these 3 new PML cases were from. The reasons for the discrepency can only be speculative at this point but it appears that the longer one is on Tysabri, the higher the risk.

Harry


The following quote is directly from the Biogen Idec website, and probably where some of these other news sites had been getting their information. Biogen was updating this particular list regularly and we were all following along until they finally announced that this would be the last time. It's still on the site, although it hasn't been updated.

It's unclear to me, from reading the FDA report posted, whether the 3 new cases include the last one reported on the list below, since it was actually reported by Biogen in July.

http://investor.biogenidec.com/phoenix. ... =irol-TPME

TYSABRI Update
Patients Treated with TYSABRI as of the end of June 2009:
Cumulatively, in the combined clinical trial and post-marketing settings, approximately 61,200 patients have been treated with TYSABRI. Of these, approximately 56,500 patients have been treated in the post-marketing setting.

In the post-marketing setting only and since the reintroduction of TYSABRI in July 2006, approximately
• 30,600 patients have received at least one year of TYSABRI therapy,
• 18,400 patients have received at least 18 months of TYSABRI therapy,
• 10,000 patients have received at least 24 months of TYSABRI therapy.

As of the end of June 2009:
• Approximately 43,300 patients were on TYSABRI therapy worldwide; of these:
• In the U.S., approximately 22,000 patients were on TYSABRI therapy
commercially;
• In the rest of world, approximately 20,700 patients were on TYSABRI therapy
commercially; and
• In global clinical trials, approximately 600 patients were on TYSABRI therapy.

Progressive multifocal leukoencephalopathy (PML):
In the period between the reintroduction and approval of TYSABRI in July 2006 and July 24, 2009, the following cases of PML have been confirmed:

Date of PML Confirmation - Duration of TYSABRI Therapy - Treated Indication - Geography

July 24, 2009 - 29 doses - MS - US
June 23, 2009 - 30 months - MS - Ex-US
June 19, 2009 - 34 doses - MS - Ex-US
June 10, 2009 - 35 doses - MS - Ex-US
May 18, 2009 - 24 doses - MS - US
April 15, 2009 - 31 months - MS - Ex-US
February 5, 2009 - 12 months - MS - Ex-US
December 10, 2008 - 26 months - MS - Ex-US
October 29, 2008 - 14 doses - MS - US
July 31, 2008 - 14 months - MS - Ex-US
July 30, 2008 - 17 months - MS - Ex-US

Final TYSABRI Website Update
This TYSABRI Update will be available on the Biogen Idec website until 4:30 PM on Tuesday, July 28, 2009, and is the final posting of this information that will appear on the Biogen Idec website.
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Postby screamner » Thu Oct 01, 2009 1:47 am

I'm only a silent reader, but advise you a german blog. He is very well informed an made especially for Ty user an english version.

http://chefarztfrau.de/?page_id=716
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Postby HarryZ » Fri Oct 02, 2009 7:28 am

Looks like the SEC is investigating Elan over its disclosure of info on PML . It never seems to end with this drug!

http://www.miamiherald.com/business/nat ... 57999.html

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Postby HarryZ » Fri Oct 23, 2009 10:29 am

Good grief...the number of PML cases has jumped from 13 to 23 in one month!!! This is not good.

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