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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.

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.

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

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.