Multiple Sclerosis (MS) Support Group

The European Medicines Agency said it has initiated the review to discuss any additional measures necessary to ensure the safe use of Tysabri.

http://uk.reuters.com/article/idUK...

So it may be that the European TYgaris program will become more similare to the US Touch program.

In May 09, after there was 9 confirmed PML cases I posted the fact that 2 of the 9 confirmed cases had happened outside the Tygaris monitoring system.

So it might be that the eurpopean Tygaris system may one day resemble the US touch program.

I'm uncertain of the differences between the two.

Tygaris is VOLUNTARY in the EU. And actually 2 of the PML cases had been outside of the Tygaris monitoring program. That was interesting to learn. That was in May 09 and there were 9 confirmed PML cases.

The EU review may make Tygaris participation Manditory?

In USA...Touch Program
In Canada.....Care Program
In Europe....TYGRIS Program (TYsabri Global Observational Program in Safety)

FROM:

European Medicines Agency

Press office
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09
E-mail: mail@emea.europa.eu http://www.emea.europa.eu
London, 23 October 2009
Doc. Ref. EMEA/CHMP/671190/2009
PRESS RELEASE
Meeting highlights from the Committee for Medicinal Products for Human Use,
19-22 October 2009
Update

Review of benefits and risks for Tysabri started
The Committee started a review of the benefits and risks of Tysabri, in view of reports of 23 cases of progressive multifocal leukoencephalopathy (PML) worldwide since Tysabri has been on the market. This review is initiated to discuss any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment. Tysabri is indicated for patients suffering from highly active relapsing remitting multiple sclerosis with high disease activity despite treatment with a beta-interferon and for patients with rapidly evolving severe relapsing-remitting multiple sclerosis.

http://www.emea.europa.eu/pdfs/human/press/pr/67119009en.pdf

Two More articles:

http://www.fool.com/investing/high...

&

http://www.newsinferno.com/archive...

According to The Wall Street Journal, CHMP has reported 23 cases of PML among Tysabri patients since the. The U.S. Food & Drug Administration (FDA) confirmed this number, the Journal said, and added that those cases occurred after Tysabri returned to the market in 2006. Previously, that number stood at 13.

Finally something I have been saying for a long time. Thank you Wall street Journal...

http://online.wsj.com/article/BT-C...

NEW YORK (Dow Jones)--Biogen Idec Inc.'s (BIIB) refusal to disclose new cases of a severe brain infection among multiple-sclerosis patients taking its Tysabri drug has raised questions about its disclosure policies.

The Cambridge, Mass., biotech company believes those developments aren't material news because the risk profile for developing progressive multifocal leukoencephalopathy, or PML, is well defined, and providing such information isn't beneficial for patients, physicians or investors unless that profile changes. As the company notes, the drug's label implies a risk rate of one in every thousand patients.

However, knowing the risk rate didn't prevent Biogen shares Friday from dropping ......

Oh the title of the article above is ...

Biogen's Tysabri Disclosure Policies Raise Questions

And this one....

http://www.medicalnewstoday.com/ar...

European Drug Agency To Weigh Risks/Benefits Of Tysabri -- Cites 23 Cases Of PML
27 Oct 2009

Today the EMEA, the European equivalent of the U.S. Food and Drug Administration, released a statement indicating that one of its advisory committees was launching a review of the risks and benefits of Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) in light of 23 confirmed cases of PML that it says have occurred since the drug has been on the market. PML (progressive multifocal leukoencephalopathy) is a viral infection of the brain that usually leads to death or severe disability. (This number of cases is still within the anticipated frequency of 1 in 1,000 indicated in the drug's labeling.)

Unlike the situation in the U.S, there is no unified risk management strategy in place across Europe for the administration of Tysabri. In the U.S., the drug is administered only to patients registered with the company's TOUCH program.

The National MS Society will follow the European panel's deliberations on the safety of Tysabri and any new thoughts they might have on balancing the risks and benefits of this therapy for people with MS.

Source
National MS Society