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 FDA-Approved Drugs: Complete FDA Biologics Application for Tysabri

Tysabri (Antegren or Natalizumab)

This is not "new" information per se, but for those of you that want all the Tysabri information you can get your hands on, one of our members has dug up the original Biologics Application for Tysabri (what Elan/Biogen submitted to the FDA for the original approval of the therapy). This was made available by a Freedom of Information Application (not ours).

This two part do*****ent is nearly 100 pages long and goes to great detail about the drug and its effect on patients (although only including the one year trial data that was available at the time of publication). Interesting sections include 2.4 "Important Issues with Pharmacologically Related Products" and Section 7, "Integrated Review of Safety." Among other things, you will find a number of ominous warnings about the risks of combining multiple immuno-modulating therapies, and furthermore, it provides details on the 9 total deaths that occurred during the trial-- 3 of which were placebo patients!

To our knowledge, this information has not been widely circulated in the MS patient community to this point. We hope you find it useful.

Click "read more" for the links to the FDA site containing these excellent do*****ents.

Link to FDA Articles

Tysabri Biologics License Application to US FDA Part 1

Tysabri Biologics License Application to US FDA Part 2




 
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· More about Tysabri (Antegren or Natalizumab)
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Most read story about Tysabri (Antegren or Natalizumab):
Revealing Medical History of 3rd Tysabri Patient with PML


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Re: Complete FDA Biologics Application for Tysabri (Score: 1)
by NHE on Wednesday, June 08 @ 06:03:53 CDT
(User Info | Send a Message)
There appears to be an error with the links to the articles. They both point to the same file. The first URL for "Part 1" should end with P1.pdf not P2.pdf.






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